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RecallWatchMedical Device Safety
Class IIOngoingZ-0753-2025

Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a…

Abbott MedicalSylmar, CA, United StatesReported Jan 1, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

Lot / code information

Model
3650
UDI
code: 05414734509725 Software Version Number /
Serial #
28.0.1 REV 2 12995 28.0.1 REV 2 16103 28.0.1 REV 2 30831 28.0.1 REV 2 12040778 28.0.1 REV 2 12041825 28.0.1 REV 2 12048943 28.0.1 REV 2 12050154 28.0.1 REV 2 12051352 28.0.1 REV 2 12051615 28.0.1 REV…Show all
28.0.1 REV 2 12995 28.0.1 REV 2 16103 28.0.1 REV 2 30831 28.0.1 REV 2 12040778 28.0.1 REV 2 12041825 28.0.1 REV 2 12048943 28.0.1 REV 2 12050154 28.0.1 REV 2 12051352 28.0.1 REV 2 12051615 28.0.1 REV 2 12056133 28.0.1 REV 2 12713 28.0.1 REV 2 14655 28.0.1 REV 2 23324 28.0.1 REV 2 24050 28.0.1 REV 2 12042174 28.0.1 REV 2 12042239 28.0.1 REV 2 12048730 28.0.1 REV 2 11959 28.0.1 REV 2 16116 28.0.1 REV 2 16571 28.0.1 REV 2 27499 28.0.1 REV 2 12056125 28.0.1 REV 2 15378 28.0.1 REV 2 18041 28.0.1 REV 2 27164 28.0.1 REV 2 12045425 28.0.1 REV 2 12045483 28.0.1 REV 2 12870 28.0.1 REV 2 14910 28.0.1 REV 2 18143 28.0.1 REV 2 21904 28.0.1 REV 2 23317 28.0.1 REV 2 12043799 28.0.1 REV 2 12044806 28.0.1 REV 2 12055973 28.0.1 REV 2 24842 28.0.1 REV 2 12040739 28.0.1 REV 2 12042686 28.0.1 REV 2 12044212 28.0.1 REV 2 12045527 28.0.1 REV 2 12052141 28.0.1 REV 2 12055384 28.0.1 REV 2 12052537 28.0.1 REV 2 19660 28.0.1 REV 2 21099 28.0.1 REV 2 24610 28.0.1 REV 2 30022 28.0.1 REV 2 12044540 28.0.1 REV 2 12047076 28.0.1 REV 2 12053304 28.0.1 REV 2 12706 28.0.1 REV 2 20207 28.0.1 REV 2 20933 28.0.1 REV 2 22212 28.0.1 REV 2 25022 28.0.1 REV 2 27371 28.0.1 REV 2 12044759 28.0.1 REV 2 12045223 28.0.1 REV 2 12052322 28.0.1 REV 2 12056132 28.0.1 REV 2 12060627 28.0.1 REV 2 12061640 28.0.1 REV 2 11628 28.0.1 REV 2 11891 28.0.1 REV 2 20861 28.0.1 REV 2 22163 28.0.1 REV 2 25164 28.0.1 REV 2 25942 28.0.1 REV 2 26189 28.0.1 REV 2 12040940 28.0.1 REV 2 12041991 28.0.1 REV 2 12045260 28.0.1 REV 2 12046359 28.0.1 REV 2 12051613 28.0.1 REV 2 12052588 28.0.1 REV 2 12055272 28.0.1 REV 2 12061523 28.0.1 REV 2 12073 28.0.1 REV 2 12386 28.0.1 REV 2 21011 28.0.1 REV 2 22744 28.0.1 REV 2 23629 28.0.1 REV 2 23881 28.0.1 REV 2 12048206 28.0.1 REV 2 12048470 28.0.1 REV 2 12138 28.0.1 REV 2 12330 28.0.1 REV 2 16714 28.0.1 REV 2 20209 28.0.1 REV 2 21538 28.0.1 REV 2 23327 28.0.1 REV 2 24046 28.0.1 REV 2 25837 28.0.1 REV 2 12050165 28.0.1 REV 2 12051284 28.0.1 REV 2 12055859 28.0.1 REV 2 12055880 28.0.1 REV 2 16005 28.0.1 REV 2 12044210 28.0.1 REV 2 12044518 28.0.1 REV 2 12045375 28.0.1 REV 2 15043 28.0.1 REV 2 16127 28.0.1 REV 2 20025 28.0.1 REV 2 20956 28.0.1 REV 2 23113 28.0.1 REV 2 12042772 28.0.1 REV 2 12043605 28.0.1 REV 2 12048109 28.0.1 REV 2 11809 28.0.1 REV 2 16010 28.0.1 REV 2 25882 28.0.1 REV 2 26257 28.0.1 REV 2 27159 28.0.1 REV 2 12042806 28.0.1 REV 2 12061445 28.0.1 REV 2 11991 28.0.1 REV 2 12554 28.0.1 REV 2 16954 28.0.1 REV 2 17842 28.0.1 REV 2 20400 28.0.1 REV 2 26405 28.0.1 REV 2 12041928 28.0.1 REV 2 12044597 28.0.1 REV 2 12048812 28.0.1 REV 2 12060584 28.0.1 REV 2 24146 28.0.1 REV 2 12046557 28.0.1 REV 2 12048311 28.0.1 REV 2 12060407 28.0.1 REV 2 15175 28.0.1 REV 2 19180 28.0.1 REV 2 12045434 28.0.1 REV 2 12052162 28.0.1 REV 2 12055217 28.0.1 REV 2 11577 28.0.1 REV 2 16703 28.0.1 REV 2 16840 28.0.1 REV 2 19150 28.0.1 REV 2 26198 28.0.1 REV 2 26493 28.0.1 REV 2 28038 28.0.1 REV 2 12044032 28.0.1 REV 2 12050131 28.0.1 REV 2 12052590 28.0.1 REV 2 12055295 28.0.1 REV 2 12060629 28.0.1 REV 2 15257 28.0.1 REV 2 17658 28.0.1 REV 2 30735 28.0.1 REV 2 12045895 28.0.1 REV 2 12046696 28.0.1 REV 2 12047207 28.0.1 REV 2 12050175 28.0.1 REV 2 12051144 28.0.1 REV 2 22419 28.0.1 REV 2 22943 28.0.1 REV 2 30704 28.0.1 REV 2 12040805 28.0.1 REV 2 12044618 28.0.1 REV 2 12046363 28.0.1 REV 2 25194 28.0.1 REV 2 12045242 28.0.1 REV 2 12045276 28.0.1 REV 2 12051266 28.0.1 REV 2 11373 28.0.1 REV 2 18152 28.0.1 REV 2 12040924 28.0.1 REV 2 12041295 28.0.1 REV 2 22299 28.0.1 REV 2 24386 28.0.1 REV 2 24492 28.0.1 REV 2 25569 28.0.1 REV 2 12048312 28.0.1 REV 2 12048422 28.0.1 REV 2 12051199 28.0.1 REV 2 12052525 28.0.1 REV 2 11635 28.0.1 REV 2 17295 28.0.1 REV 2 20479 28.0.1 REV 2 23627 28.0.1 REV 2 12044434 28.0.1 REV 2 12045558 28.0.1 REV 2 12055864 28.0.1 REV 2 16105 28.0.1 REV 2 24762 28.0.1 REV 2 25147 28.0.1 REV 2 26011 28.0.1 REV 2 12041951 28.0.1 REV 2 12051079 28.0.1 REV 2 12051168 28.0.1 REV 2 12060736 28.0.1 REV 2 15926 28.0.1 REV 2 21177 28.0.1 REV 2 30016 28.0.1 REV 2 12060805 28.0.1 REV 2 16966 28.0.1 REV 2 20250 28.0.1 REV 2 20886 28.0.1 REV 2 21876 28.0.1 REV 2 24760 28.0.1 REV 2 26628 28.0.1 REV 2 27295 28.0.1 REV 2 27700 28.0.1 REV 2 27933 28.0.1 REV 2 12047177 28.0.1 REV 2 12048506 28.0.1 REV 2 12049432 28.0.1 REV 2 12060785 28.0.1 REV 2 24999 28.0.1 REV 2 12048294 28.0.1 REV 2 16828 28.0.1 REV 2 16907 28.0.1 REV 2 22241 28.0.1 REV 2 24884 28.0.1 REV 2 25075 28.0.1 REV 2 23091 28.0.1 REV 2 24696 28.0.1 REV 2 25999 28.0.1 REV 2 30823 28.0.1 REV 2 12045679 28.0.1 REV 2 12052118 28.0.1 REV 2 12052305 28.0.1 REV 2 18554 28.0.1 REV 2 20197 28.0.1 REV 2 21939 28.0.1 REV 2 23161 28.0.1 REV 2 25940 28.0.1 REV 2 12042222 28.0.1 REV 2 12046932 28.0.1 REV 2 12051416 28.0.1 REV 2 12055874 28.0.1 REV 2 19968 28.0.1 REV 2 21014 28.0.1 REV 2 25308 28.0.1 REV 2 25876 28.0.1 REV 2 12049933 28.0.1 REV 2 12061366 28.0.1 REV 2 21140 28.0.1 REV 2 24552 28.0.1 REV 2 12044482 28.0.1 REV 2 23466 28.0.1 REV 2 23422 28.0.1 REV 2 11688 28.0.1 REV 2 12052631 28.0.1 REV 2 25422 28.0.1 REV 2 12045682 28.0.1 REV 2 24946 28.0.1 REV 2 20876 28.0.1 REV 2 12049422 28.0.1 REV 2 25962 28.0.1 REV 2 12043694 28.0.1 REV 2 19241 28.0.1 REV 2 20042 28.0.1 REV 2 23762 28.0.1 REV 2 12048510 28.0.1 REV 2 12051108 28.0.1 REV 2 12061482 28.0.1 REV 2 12048450 28.0.1 REV 2 19699 28.0.1 REV 2 12052609 28.0.1 REV 2 14964 28.0.1 REV 2 21909 28.0.1 REV 3 15024 28.0.1 REV 3 15071 28.0.1 REV 3 15394 28.0.1 REV 3 17875 28.0.1 REV 3 12041047 28.0.1 REV 3 12042155 28.0.1 REV 3 14785 28.0.1 REV 3 14882 28.0.1 REV 3 15272 28.0.1 REV 3 15645 28.0.1 REV 3 19453 28.0.1 REV 3 21665 28.0.1 REV 3 23850 28.0.1 REV 3 25024 28.0.1 REV 3 12044251 28.0.1 REV 3 12052328 28.0.1 REV 3 11971 28.0.1 REV 3 16152 28.0.1 REV 3 20827 28.0.1 REV 3 27705 28.0.1 REV 3 12044657 28.0.1 REV 3 12049919 28.0.1 REV 3 12056081 28.0.1 REV 3 12061517 28.0.1 REV 3 12061540 28.0.1 REV 3 26178 28.0.1 REV 3 12041349 28.0.1 REV 3 14075 28.0.1 REV 3 15373 28.0.1 REV 3 19105 28.0.1 REV 3 19228 28.0.1 REV 3 21087 28.0.1 REV …
Additional code information

523 28.1.2 REV 1 11543 28.1.2 REV 1 12041500 28.1.2 REV 1 12041992 28.1.2 REV 1 12042118 28.1.2 REV 1 12043338 28.1.2 REV 1 12044866 28.1.2 REV 1 12052934 28.1.2 REV 1 12053608 28.1.2 REV 1 12054408 28.1.2 REV 1 12054456 28.1.2 REV 1 12369 28.1.2 REV 1 12973 28.1.2 REV 1 13914 28.1.2 REV 1 17276 28.1.2 REV 1 17586 28.1.2 REV 1 17793 28.1.2 REV 1 18776 28.1.2 REV 1 18930 28.1.2 REV 1 19759 28.1.2 REV 1 21431 28.1.2 REV 1 22086 28.1.2 REV 1 30310 28.1.2 REV 1 30550 28.1.2 REV 1 12047264 28.1.2 REV 1 12049109 28.1.2 REV 1 12053065 28.1.2 REV 1 12063445 28.1.2 REV 1 12064175 28.1.2 REV 1 12612 28.1.2 REV 1 12876 28.1.2 REV 1 13292 28.1.2 REV 1 14362 28.1.2 REV 1 14868 28.1.2 REV 1 17776 28.1.2 REV 1 18371 28.1.2 REV 1 18852 28.1.2 REV 1 24616 28.1.2 REV 1 27594 28.1.2 REV 1 30464 28.1.2 REV 1 12046063 28.1.2 REV 1 12047646 28.1.2 REV 1 12049878 28.1.2 REV 1 12051200 28.1.2 REV 1 12053111 28.1.2 REV 1 12055836 28.1.2 REV 1 21466 28.1.2 REV 1 21478 28.1.2 REV 1 12042087 28.1.2 REV 1 12056522 28.1.2 REV 1 26143 28.1.2 REV 1 25532 28.1.2 REV 1 27575 28.1.2 REV 1 13056 28.1.2 REV 1 16933 28.1.2 REV 1 18938 28.1.2 REV 1 20616 28.1.2 REV 1 12045928 28.1.2 REV 1 12049164 28.1.2 REV 1 15134 28.1.2 REV 1 22863 28.1.2 REV 1 12044542 28.1.2 REV 1 13174 28.1.2 REV 1 15515 28.1.2 REV 1 19205 28.1.2 REV 1 12044350 28.1.2 REV 1 12044744 28.1.2 REV 1 12048631 28.1.2 REV 1 18275 28.1.2 REV 1 12063835 28.1.2 REV 1 12047530 28.1.2 REV 1 12054284 28.1.2 REV 1 14477 28.1.2 REV 1 14487 28.1.2 REV 1 12787 28.1.2 REV 1 15557 28.1.2 REV 1 16854 28.1.2 REV 1 12041737 28.1.2 REV 1 12043696 28.1.2 REV 1 12043739 28.1.2 REV 1 12044286 28.1.2 REV 1 12049835 28.1.2 REV 1 12053148 28.1.2 REV 1 12054207 28.1.2 REV 1 12054267 28.1.2 REV 1 12054303 28.1.2 REV 1 12056187 28.1.2 REV 1 13472 28.1.2 REV 1 14242 28.1.2 REV 1 14602 28.1.2 REV 1 18274 28.1.2 REV 1 30270 28.1.2 REV 1 30383 28.1.2 REV 1 12047538 28.1.2 REV 1 18534 28.1.2 REV 1 12041561 28.1.2 REV 1 12042949 28.1.2 REV 1 21620 28.1.2 REV 1 26673 28.1.2 REV 1 12048653 28.1.2 REV 1 12063553 28.1.2 REV 1 12044860 28.1.2 REV 1 13385 28.1.2 REV 1 12043137 28.1.2 REV 1 12047541 28.1.2 REV 1 12049818 28.1.2 REV 1 12049859 28.1.2 REV 1 12052415 28.1.2 REV 1 12063599 28.1.2 REV 1 15750 28.1.2 REV 1 22705 28.1.2 REV 1 12044330 28.1.2 REV 1 12044631 28.1.2 REV 1 12045912 28.1.2 REV 1 12045947 28.1.2 REV 1 12049028 28.1.2 REV 1 12055536 28.1.2 REV 1 13154 28.1.2 REV 1 14352 28.1.2 REV 1 17050 28.1.2 REV 1 20744 28.1.2 REV 1 27198 28.1.2 REV 1 12042293 28.1.2 REV 1 12043314 28.1.2 REV 1 12044233 28.1.2 REV 1 12045966 28.1.2 REV 1 12046537 28.1.2 REV 1 12049816 28.1.2 REV 1 12054214 28.1.2 REV 1 12063477 28.1.2 REV 1 12063536 28.1.2 REV 1 13402 28.1.2 REV 1 16183 28.1.2 REV 1 16264 28.1.2 REV 1 19167 28.1.2 REV 1 12041132 28.1.2 REV 1 12042337 28.1.2 REV 1 12042418 28.1.2 REV 1 12042849 28.1.2 REV 1 12043017 28.1.2 REV 1 12043036 28.1.2 REV 1 12043053 28.1.2 REV 1 12043211 28.1.2 REV 1 12044099 28.1.2 REV 1 12044260 28.1.2 REV 1 12044296 28.1.2 REV 1 12044366 28.1.2 REV 1 12044410 28.1.2 REV 1 12044817 28.1.2 REV 1 12046265 28.1.2 REV 1 12046317 28.1.2 REV 1 12046474 28.1.2 REV 1 12047420 28.1.2 REV 1 12047575 28.1.2 REV 1 12047700 28.1.2 REV 1 12048974 28.1.2 REV 1 12048979 28.1.2 REV 1 12048996 28.1.2 REV 1 12049672 28.1.2 REV 1 12049743 28.1.2 REV 1 12049746 28.1.2 REV 1 12049884 28.1.2 REV 1 12050634 28.1.2 REV 1 12050718 28.1.2 REV 1 12051381 28.1.2 REV 1 12052219 28.1.2 REV 1 12052231 28.1.2 REV 1 12052406 28.1.2 REV 1 12052417 28.1.2 REV 1 12052438 28.1.2 REV 1 12052452 28.1.2 REV 1 12053562 28.1.2 REV 1 12053718 28.1.2 REV 1 12054151 28.1.2 REV 1 12054291 28.1.2 REV 1 12054479 28.1.2 REV 1 12054804 28.1.2 REV 1 12673 28.1.2 REV 1 12841 28.1.2 REV 1 12869 28.1.2 REV 1 12886 28.1.2 REV 1 12904 28.1.2 REV 1 13349 28.1.2 REV 1 13370 28.1.2 REV 1 13375 28.1.2 REV 1 13612 28.1.2 REV 1 14022 28.1.2 REV 1 14032 28.1.2 REV 1 14126 28.1.2 REV 1 14138 28.1.2 REV 1 14160 28.1.2 REV 1 14181 28.1.2 REV 1 14232 28.1.2 REV 1 14270 28.1.2 REV 1 15579 28.1.2 REV 1 16645 28.1.2 REV 1 18883 28.1.2 REV 1 18908 28.1.2 REV 1 19015 28.1.2 REV 1 19048 28.1.2 REV 1 19659 28.1.2 REV 1 21382 28.1.2 REV 1 21419 28.1.2 REV 1 21425 28.1.2 REV 1 23761 28.1.2 REV 1 23918 28.1.2 REV 1 26743 28.1.2 REV 1 26774 28.1.2 REV 1 26850 28.1.2 REV 1 26857 28.1.2 REV 1 27246 28.1.2 REV 1 27257 28.1.2 REV 1 30105 28.1.2 REV 1 30348 28.1.2 REV 1 30376 28.1.2 REV 1 12064050 28.1.2 REV 1 12064106 28.1.2 REV 1 12042289 28.1.2 REV 1 12045296 28.1.2 REV 1 12049070 28.1.2 REV 1 12051224 28.1.2 REV 1 12052180 28.1.2 REV 1 12063615 28.1.2 REV 1 13346 28.1.2 REV 1 14320 28.1.2 REV 1 15566 28.1.2 REV 1 16188 28.1.2 REV 1 18276 28.1.2 REV 1 18377 28.1.2 REV 1 18461 28.1.2 REV 1 18581 28.1.2 REV 1 18719 28.1.2 REV 1 24611 28.1.2 REV 1 30519 28.1.2 REV 1 12045582 28.1.2 REV 1 12046997 28.1.2 REV 1 14425 28.1.2 REV 1 21817 28.1.2 REV 1 22950 28.1.2 REV 1 15788 28.1.2 REV 1 19867 28.1.2 REV 1 20731 28.1.2 REV 1 12043074 28.1.2 REV 1 12043711 28.1.2 REV 1 12044346 28.1.2 REV 1 12046475 28.1.2 REV 1 12049845 28.1.2 REV 1 12049885 28.1.2 REV 1 12051295 28.1.2 REV 1 12051499 28.1.2 REV 1 12053037 28.1.2 REV 1 12053098 28.1.2 REV 1 12054170 28.1.2 REV 1 12054175 28.1.2 REV 1 12063688 28.1.2 REV 1 12063747 28.1.2 REV 1 13310 28.1.2 REV 1 14564 28.1.2 REV 1 16532 28.1.2 REV 1 16786 28.1.2 REV 1 18541 28.1.2 REV 1 22370 28.1.2 REV 1 22476 28.1.2 REV 1 30284 28.1.2 REV 1 12042302 28.1.2 REV 1 12042395 28.1.2 REV 1 12048868 28.1.2 REV 1 12049115 28.1.2 REV 1 12051189 28.1.2 REV 1 12056558 28.1.2 REV 1 12063689 28.1.2 REV 1 13731 28.1.2 REV 1 17233 28.1.2 REV 1 30094 28.1.2 REV 1 12045918 28.1.2 REV 1 12046146 28.1.2 REV 1 12053097 28.1.2 REV 1 12054101 28.1.2 REV 1 17099 28.1.2 REV 1 18797 28.1.2 REV 1 21594 28.1.2 REV 1 12063730 28.1.2 REV 1 12063770 28.1.2 REV 1 12063860 28.1.2 REV 1 18728 28.1.2 REV 1 12884 28.1.2 REV 1 16971 28.1.2 REV 1 18713 28.1.2 REV 1 21628 28.1.2 REV 1 21680 28.1.2 REV 1 12055756 28.1.2 REV 1 12062119 28.1.2 REV 1 12776 28.1.2 REV 1 16975 28.1.2 REV 1 17087 28.1.2 REV 1 18838 28.1.2 REV 1 21685 28.1.2 REV 1 12042281 28.1.2 REV 1 12043319 28.1.2 REV 1 12045614 28.1.2 REV 1 12047634 28.1.2 REV 1 12048839 28.1.2 REV 1 12322 28.1.2 REV 1 13468 28.1.2 REV 1 13655 28.1.2 REV 1 14724 28.1.2 REV 1 14933 28.1.2 REV 1 17095 28.1.2 REV 1 17730 28.1.2 REV 1 19071 28.1.2 REV 1 21442 28.1.2 REV 1 21505 28.1.2 REV 1 30195 28.1.2 REV 1 12043961 28.1.2 REV 1 12046197 28.1.2 REV 1 12046269 28.1.2 REV 1 12046502 28.1.2 REV 1 12047492 28.1.2 REV 1 12048585 28.1.2 REV 1 12048599 28.1.2 REV 1 12048864 28.1.2 REV 1 12049067 28.1.2 REV 1 12049834 28.1.2 REV 1 12051271 28.1.2 REV 1 12051872 28.1.2 REV 1 12052330 28.1.2 REV 1 12052419 28.1.2 REV 1 12054346 28.1.2 REV 1 12055424 28.1.2 REV 1 12055478 28.1.2 REV 1 12055535 28.1.2 REV 1 12055557 28.1.2 REV 1 12055743 28.1.2 REV 1 12793 28.1.2 REV 1 12976 28.1.2 REV 1 13358 28.1.2 REV 1 13462 28.1.2 REV 1 13539 28.1.2 REV 1 13628 28.1.2 REV 1 13649 28.1.2 REV 1 13651 28.1.2 REV 1 13665 28.1.2 REV 1 14041 28.1.2 REV 1 14149 28.1.2 REV 1 14206 28.1.2 REV 1 14226 28.1.2 REV 1 14259 28.1.2 REV 1 14266 28.1.2 REV 1 14275 28.1.2 REV 1 16989 28.1.2 REV 1 16992 28.1.2 REV 1 17017 28.1.2 REV 1 17028 28.1.2 REV 1 17075 28.1.2 REV 1 17079 28.1.2 REV 1 17085 28.1.2 REV 1 17089 28.1.2 REV 1 17098 28.1.2 REV 1 17127 28.1.2 REV 1 18768 28.1.2 REV 1 18770 28.1.2 REV 1 18835 28.1.2 REV 1 18840 28.1.2 REV 1 19357 28.1.2 REV 1 20323 28.1.2 REV 1 20979 28.1.2 REV 1 21070 28.1.2 REV 1 21328 28.1.2 REV 1 21599 28.1.2 REV 1 21609 28.1.2 REV 1 21617 28.1.2 REV 1 21652 28.1.2 REV 1 21690 28.1.2 REV 1 21717 28.1.2 REV 1 22277 28.1.2 REV 1 30030 28.1.2 REV 1 30520 28.1.2 REV 1 12043992 28.1.2 REV 1 13245 28.1.2 REV 1 15850 28.1.2 REV 1 25416 28.1.2 REV 1 14001 28.1.2 REV 1 14003 28.1.2 REV 1 17715 28.1.2 REV 1 13474 28.1.2 REV 1 14064 28.1.2 REV 1 20091 28.1.2 REV 1 12044274 28.1.2 REV 1 12044291 28.1.2 REV 1 12044320 28.1.2 REV 1 12045917 28.1.2 REV 1 12048602 28.1.2 REV 1 12053604 28.1.2 REV 1 12965 28.1.2 REV 1 12987 28.1.2 REV 1 13526 28.1.2 REV 1 13962 28.1.2 REV 1 15618 28.1.2 REV 1 16465 28.1.2 REV 1 16611 28.1.2 REV 1 17196 28.1.2 REV 1 17264 28.1.2 REV 1 17819 28.1.2 REV 1 18667 28.1.2 REV 1 22773 28.1.2 REV 1 22847 28.1.2 REV 1 12046075 28.1.2 REV 1 12047408 28.1.2 REV 1 12050713 28.1.2 REV 1 15554 28.1.2 REV 1 12043777 28.1.2 REV 1 12051447 28.1.2 REV 1 20676 28.1.2 REV 1 30453 28.1.2 REV 1 12063548 28.1.2 REV 1 12063568 28.1.2 REV 1 12063626 28.1.2 REV 1 12063744 28.1.2 REV 1 12041765 28.1.2 REV 1 12052467 28.1.2 REV 1 12060912 28.1.2 REV 1 16286 28.1.2 REV 1 18994 28.1.2 REV 1 30356 28.1.2 REV 1 12045867 28.1.2 REV 1 12050385 28.1.2 REV 1 14331 28.1.2 REV 1 14749 28.1.2 REV 1 22082 28.1.2 REV 1 12046046 28.1.2 REV 1 12063661 28.1.2 REV 1 12063805 28.1.2 REV 1 14905 28.1.2 REV 1 12048881 28.1.2 REV 1 12049776 28.1.2 REV 1 12049973 28.1.2 REV 1 12050268 28.1.2 REV 1 12050717 28.1.2 REV 1 12051239 28.1.2 REV 1 12052732 28.1.2 REV 1 12052750 28.1.2 REV 1 12056211 28.1.2 REV 1 12056223 28.1.2 REV 1 12056589 28.1.2 REV 1 12056591 28.1.2 REV 1 12061001 28.1.2 REV 1 12063792 28.1.2 REV 1 13242 28.1.2 REV 1 13771 28.1.2 REV 1 14526 28.1.2 REV 1 14668 28.1.2 REV 1 14746 28.1.2 REV 1 14874 28.1.2 REV 1 15972 28.1.2 REV 1 16247 28.1.2 REV 1 17111 28.1.2 REV 1 17406 28.1.2 REV 1 18232 28.1.2 REV 1 21587 28.1.2 REV 1 12042274 28.1.2 REV 1 12046093 28.1.2 REV 1 12049962 28.1.2 REV 1 12051422 28.1.2 REV 1 12055610 28.1.2 REV 1 16327 28.1.2 REV 1 17195 28.1.2 REV 1 18324 28.1.2 REV 1 12041739 28.1.2 REV 1 12041787 28.1.2 REV 1 12041791 28.1.2 REV 1 12043057 28.1.2 REV 1 12043070 28.1.2 REV 1 12043158 28.1.2 REV 1 12043182 28.1.2 REV 1 12044035 28.1.2 REV 1 12044306 28.1.2 REV 1 12044311 28.1.2 REV 1 12044638 28.1.2 REV 1 12044888 28.1.2 REV 1 12045924 28.1.2 REV 1 12045938 28.1.2 REV 1 12045995 28.1.2 REV 1 12046689 28.1.2 REV 1 12046925 28.1.2 REV 1 12047255 28.1.2 REV 1 12047785 28.1.2 REV 1 12048603 28.1.2 REV 1 12048611 28.1.2 REV 1 12048620 28.1.2 REV 1 12048636 28.1.2 REV 1 12048637 28.1.2 REV 1 12048663 28.1.2 REV 1 12048704 28.1.2 REV 1 12048937 28.1.2 REV 1 12048951 28.1.2 REV 1 12049020 28.1.2 REV 1 12049161 28.1.2 REV 1 12049171 28.1.2 REV 1 12049187 28.1.2 REV 1 12049768 28.1.2 REV 1 12049819 28.1.2 REV 1 12049826 28.1.2 REV 1 12050029 28.1.2 REV 1 12050031 28.1.2 REV 1 12050215 28.1.2 REV 1 12050301 28.1.2 REV 1 12050312 28.1.2 REV 1 12050772 28.1.2 REV 1 12051208 28.1.2 REV 1 12051217 28.1.2 REV 1 12051247 28.1.2 REV 1 12051254 28.1.2 REV 1 12051262 28.1.2 REV 1 12051404 28.1.2 REV 1 12052426 28.1.2 REV 1 12052448 28.1.2 REV 1 12052739 28.1.2 REV 1 12052741 28.1.2 REV 1 12052744 28.1.2 REV 1 12052761 28.1.2 REV 1 12054096 28.1.2 REV 1 12054280 28.1.2 REV 1 12054383 28.1.2 REV 1 12054447 28.1.2 REV 1 12054486 28.1.2 REV 1 12054785 28.1.2 REV 1 12054792 28.1.2 REV 1 12054838 28.1.2 REV 1 12054882 28.1.2 REV 1 12055561 28.1.2 REV 1 12055577 28.1.2 REV 1 12055580 28.1.2 REV 1 12055780 28.1.2 REV 1 12055790 28.1.2 REV 1 12055793 28.1.2 REV 1 12055844 28.1.2 REV 1 12056148 28.1.2 REV 1 12056155 28.1.2 REV 1 12056170 28.1.2 REV 1 12056177 28.1.2 REV 1 12056180 28.1.2 REV 1 12056490 28.1.2 REV 1 12060189 28.1.2 REV 1 12060194 28.1.2 REV 1 12060205 28.1.2 REV 1 12060253 28.1.2 REV 1 12060262 28.1.2 REV 1 12060264 28.1.2 REV 1 12060276 28.1.2 REV 1 12060966 28.1.2 REV 1 12060996 28.1.2 REV 1 12061818 28.1.2 REV 1 12061827 28.1.2 REV 1 12061873 28.1.2 REV 1 12061884 28.1.2 REV 1 12785 28.1.2 REV 1 12866 28.1.2 REV 1 12985 28.1.2 REV 1 13091 28.1.2 REV 1 13396 28.1.2 REV 1 13400 28.1.2 REV 1 14082 28.1.2 REV 1 14328 28.1.2 REV 1 14334 28.1.2 REV 1 14336 28.1.2 REV 1 14353 28.1.2 REV 1 14363 28.1.2 REV 1 14420 28.1.2 REV 1 14476 28.1.2 REV 1 14479 28.1.2 REV 1 14493 28.1.2 REV 1 14516 28.1.2 REV 1 14517 28.1.2 REV 1 14529 28.1.2 REV 1 14645 28.1.2 REV 1 14657 28.1.2 REV 1 14660 28.1.2 REV 1 14662 28.1.2 REV 1 14848 28.1.2 REV 1 14856 28.1.2 REV 1 14858 28.1.2 REV 1 14872 28.1.2 REV 1 14877 28.1.2 REV 1 14891 2 …

What the firm is doing

On 11/21/2024, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter via in person or certified mail to customers informing them that Abbott is aware of a programmer software anomaly that may incorrectly reprogram a ventricular Aveir leadless pacer during the Finalize the New LP ( Finalization ) step of the implant process for an AVEIR DR Leadless Pacemaker (LP) System. This can occur during an upgrade from an AVEIR VR to an AVEIR DR system or during a new AVEIR DR system implant. If telemetry is lost during a small window (<2 seconds) during Finalization of the Right Atrial (RA) LP after the Right Ventricular (RV) LP is Finalized, the programmer software anomaly configures the RV LP to incorrectly behave as an RA LP. If this occurs, the Merlin PCS 3650 Programmer displays a Loss of telemetry detected window, and there is no pacing. Additionally, atrial sense markers coincident to intrinsic QRS complexes may be observed. Subsequent attempts to finalize the device will continue to result in a Loss of telemetry detected window. In all cases where this occurred, full functionality, including ability to finalize the device and restore pacing, was reinstated through Abbott Technical Services intervention. Action Abbott has Taken: Currently available Merlin" PCS 3650 programmer software (version 28.2.1 rev 2) prevents this issue. An Abbott Representative will upgrade your programmer software and work with customer to ensure use of version 28.2.1 rev 2 or greater as it eliminates this issue. A list of Abbott advisories is available at https://www.cardiovascular.abbott/us/en/hcp/product-advisories.html. any questions about this notice, contact Abbott Technical Services at 1-800-722-3774 (U.S.).

DistributionShow details

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN TX, UT, VA, WA, WI, and WV. The countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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