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RecallWatchMedical Device Safety
Class IIOngoingZ-0774-2025

Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG…

Medtronic NeuromodulationMinneapolis, MN, United StatesReported Jan 8, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Software issues were identified in application version 2.x.

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.

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E

Lot / code information

GTIN
00763000447090 00763000729141 00763000737290 00763000447090
Serial #
NPL3020725 NPL3021958 NPL3021963 NPL3021966 NPL3021969 NPL3021970 NPL3021971 NPL3021974 NPL3021983 NPL3021984 NPL3021990 NPL3021997 NPL3022002 NPL3022005 NPL3022014 NPL3022022 NPL3022031 NPL3022032 NP…Show all
NPL3020725 NPL3021958 NPL3021963 NPL3021966 NPL3021969 NPL3021970 NPL3021971 NPL3021974 NPL3021983 NPL3021984 NPL3021990 NPL3021997 NPL3022002 NPL3022005 NPL3022014 NPL3022022 NPL3022031 NPL3022032 NPL3022038 NPL3022044 NPL3022052 NPL3022062 NPL3022069 NPL3022070 NPL3022071 NPL3022072 NPL3022073 NPL3022074 NPL3022109 NPL3022114 NPL3022118 NPL3022124 NPL3022125 NPL3022131 NPL3022139 NPL3022187 NPL3022190 NPL3022193 NPL3022194 NPL3022195 NPL3022212 NPL3022213 NPL3022216 NPL3022218 NPL3022245 NPL3022257 NPL3022278 NPL3022280 NPL3022289 NPL3022291 NPL3022304 NPL3022311 NPL3022313 NPL3022314 NPL3022328 NPL3022352 NPL3022357 NPL3022364 NPL3022365 NPL3022711 NPL3022713 NPL3022714 NPL3022715 NPL3022717 NPL3022735 NPL3022761 NPL3022762 NPL3022765 NPL3022767 NPL3022768 NPL3022769 NPL3022776 NPL3022791 NPL3022793 NPL3022795 NPL3022810 NPL3022811 NPL3022815 NPL3022817 NPL3022818 NPL3022831 NPL3022836 NPL3022838 NPL3022841 NPL3022844 NPL3022856 NPL3022858 NPL3022869 NPL3022870 NPL3022873 NPL3022874 NPL3022876 NPL3022877 NPL3022879 NPL3022893 NPL3022899 NPL3022900 NPL3022912 NPL3022918 NPL3022922 NPL3022926 NPL3022939 NPL3022940 NPL3022942 NPL3022954 NPL3022957 NPL3022958 NPL3022959 NPL3022968 NPL3022969 NPL3022973 NPL3022974 NPL3022981 NPL3022999 NPL3023030 NPL3023032 NPL3023035 NPL3023038 NPL3023042 NPL3023043 NPL3023048 NPL3023050 NPL3023054 NPL3023059 NPL3023061 NPL3023065 NPL3023067 NPL3023076 NPL3023078 NPL3023086 NPL3023093 NPL3023097 NPL3023123 NPL3023131 NPL3023132 NPL3023133 NPL3023136 NPL3023146 NPL3023148 NPL3023149 NPL3023150 NPL3023153 NPL3023156 NPL3023167 NPL3023175 NPL3023180 NPL3023192 NPL3023194 NPL3023197 NPL3023205 NPL3023218 NPL3023229 NPL3023237 NPL3023239 NPL3023241 NPL3023242 NPL3023245 NPL3023254 NPL3023256 NPL3023257 NPL3023260 NPL3023262 NPL3023268 NPL3023272 NPL3023278 NPL3023288 NPL3023292 NPL3023315 NPL3023317 NPL3023319 NPL3023322 NPL3023323 NPL3023330 NPL3023331 NPL3023340 NPL3023347 NPL3023351 NPL3023352 NPL3023364 NPL3023367 NPL3023368 NPL3023373 NPL3023380 NPL3023388 NPL3023389 NPL3023394 NPL3023409 NPL3023411 NPL3023415 NPL3023422 NPL3023423 NPL3023424 NPL3023425 NPL3023429 NPL3023432 NPL3023435 NPL3023437 NPL3023439 NPL3023440 NPL3023443 NPL3023446 NPL3023447 NPL3023448 NPL3023449 NPL3023450 NPL3023459 NPL3023460 NPL3023463 NPL3023464 NPL3023466 NPL3023467 NPL3023474 NPL3023491 NPL3023494 NPL3023498 NPL3023504 NPL3023510 NPL3023511 NPL3023512 NPL3023520 NPL3023526 NPL3023541 NPL3023548 NPL3023550 NPL3023554 NPL3023555 NPL3023556 NPL3023559 NPL3023563 NPL3023573 NPL3023583 NPL3023593 NPL3023597 NPL3023598 NPL3023599 NPL3023600 NPL3023602 NPL3023607 NPL3023610 NPL3023615 NPL3023620 NPL3023635 NPL3023638 NPL3023640 NPL3023642 NPL3023646 NPL3023647 NPL3023649 NPL3023651 NPL3023659 NPL3023660 NPL3023661 NPL3023664 NPL3023665 NPL3023666 NPL3023689 NPL3023690 NPL3023692 NPL3023695 NPL3023704 NPL3023708 NPL3023711 NPL3023716 NPL3023718 NPL3023722 NPL3023723 NPL3023728 NPL3023729 NPL3023734 NPL3023744 NPL3023751 NPL3023752 NPL3023760 NPL3023762 NPL3023776 NPL3023778 NPL3023781 NPL3023782 NPL3023784 NPL3023785 NPL3023792 NPL3023803 NPL3023809 NPL3023829 NPL3023830 NPL3023831 NPL3023837 NPL3023841 NPL3023852 NPL3023854 NPL3023855 NPL3023857 NPL3023858 NPL3023860 NPL3023868 NPL3023873 NPL3023885 NPL3023902 NPL3023905 NPL3023915 NPL3023922 NPL3023930 NPL3023933 NPL3023936 NPL3023938 NPL3023948 NPL3023949 NPL3023955 NPL3023957 NPL3023959 NPL3023974 NPL3023977 NPL3023980 NPL3023983 NPL3023984 NPL3023990 NPL3023991 NPL3023998 NPL3024013 NPL3024015 NPL3024022 NPL3024023 NPL3024024 NPL3024025 NPL3024026 NPL3024028 NPL3024031 NPL3024033 NPL3024037 NPL3024040 NPL3024043 NPL3024044 NPL3024046 NPL3024054 NPL3024055 NPL3024056 NPL3024059 NPL3024072 NPL3024079 NPL3024082 NPL3024084 NPL3024087 NPL3024088 NPL3024092 NPL3024099 NPL3024100 NPL3024102 NPL3024103 NPL3024108 NPL3024111 NPL3024113 NPL3024117 NPL3024122 NPL3024123 NPL3024124 NPL3024127 NPL3024129 NPL3024139 NPL3024145 NPL3024148 NPL3024149 NPL3024150 NPL3024151 NPL3024152 NPL3024153 NPL3024155 NPL3024158 NPL3024161 NPL3024162 NPL3024166 NPL3024167 NPL3024170 NPL3024176 NPL3024179 NPL3024185 NPL3024188 NPL3024193 NPL3024196 NPL3024197 NPL3024198 NPL3024199 NPL3024200 NPL3024206 NPL3024207 NPL3024208 NPL3024209 NPL3024210 NPL3024212 NPL3024218 NPL3024220 NPL3024221 NPL3024225 NPL3024230 NPL3024233 NPL3024234 NPL3024235 NPL3024239 NPL3024240 NPL3024245 NPL3024246 NPL3024247 NPL3024256 NPL3024257 NPL3024258 NPL3024261 NPL3024266 NPL3024274 NPL3024276 NPL3024277 NPL3024278 NPL3024280 NPL3024284 NPL3024294 NPL3024296 NPL3024298 NPL3024299 NPL3024300 NPL3024303 NPL3024305 NPL3024307 NPL3024308 NPL3024309 NPL3024310 NPL3024311 NPL3024312 NPL3024313 NPL3024316 NPL3024321 NPL3024324 NPL3024327 NPL3024328 NPL3024329 NPL3024337 NPL3024341 NPL3024348 NPL3024350 NPL3024355 NPL3024356 NPL3024358 NPL3024360 NPL3024367 NPL3024370 NPL3024379 NPL3024381 NPL3024384 NPL3024393 NPL3024395 NPL3024399 NPL3024404 NPL3024405 NPL3024407 NPL3024408 NPL3024416 NPL3024417 NPL3024418 NPL3024419 NPL3024420 NPL3024424 NPL3024428 NPL3024430 NPL3024437 NPL3024439 NPL3024440 NPL3024442 NPL3024452 NPL3024455 NPL3024461 NPL3024462 NPL3024464 NPL3024472 NPL3024478 NPL3024479 NPL3024480 NPL3024482 NPL3024484 NPL3024485 NPL3024486 NPL3024487 NPL3024490 NPL3024491 NPL3024492 NPL3024493 NPL3024498 NPL3024499 NPL3024501 NPL3024502 NPL3024507 NPL3024509 NPL3024518 NPL3024519 NPL3024523 NPL3024531 NPL3024533 NPL3024534 NPL3024540 NPL3024541 NPL3024542 NPL3024544 NPL3024545 NPL3024549 NPL3024550 NPL3024551 NPL3024552 NPL3024554 NPL3024555 NPL3024556 NPL3024557 NPL3024558 NPL3024559 NPL3024563 NPL3024565 NPL3024567 NPL3024569 NPL3024572 NPL3024574 NPL3024576 NPL3024578 NPL3024582 NPL3024583 NPL3024585 NPL3024587 NPL3024589 NPL3024592 NPL3024594 NPL3024596 NPL3024598 NPL3024600 NPL3024602 NPL3024603 NPL3024604 NPL3024606 NPL3024608 NPL3024610 NPL3024615 NPL3024618 NPL3024619 NPL3024621 NPL3024625 NPL3024626 NPL3024631 NPL3024632 NPL3024635 NPL3024637 NPL3024639 NPL3024642 NPL30 …
Additional code information

PL3036843 NPL3036859 NPL3036860 NPL3036863 NPL3036865 NPL3036866 NPL3036867 NPL3036871 NPL3036872 NPL3036875 NPL3036876 NPL3036877 NPL3036883 NPL3036885 NPL3036886 NPL3036889 NPL3036890 NPL3036902 NPL3036905 NPL3036908 NPL3036910 NPL3036916 NPL3036926 NPL3036927 NPL3036932 NPL3036934 NPL3036936 NPL3036940 NPL3036942 NPL3036944 NPL3036945 NPL3036946 NPL3036947 NPL3036948 NPL3036954 NPL3036956 NPL3036957 NPL3036959 NPL3036960 NPL3036962 NPL3036963 NPL3036967 NPL3036968 NPL3036969 NPL3036985 NPL3036991 NPL3036997 NPL3036999 NPL3037014 NPL3037022 NPL3037030 NPL3037038 NPL3037048 NPL3037052 NPL3037061 NPL3037062 NPL3037064 NPL3037066 NPL3037070 NPL3037072 NPL3037083 NPL3037085 NPL3037087 NPL3037088 NPL3037089 NPL3037094 NPL3037107 NPL3037108 NPL3037111 NPL3037112 NPL3037113 NPL3037115 NPL3037118 NPL3037119 NPL3037121 NPL3037123 NPL3037124 NPL3037126 NPL3037127 NPL3037131 NPL3037132 NPL3037136 NPL3037137 NPL3037139 NPL3037141 NPL3037143 NPL3037145 NPL3037146 NPL3037147 NPL3037148 NPL3037149 NPL3037150 NPL3037151 NPL3037152 NPL3037160 NPL3037163 NPL3037165 NPL3037167 NPL3037168 NPL3037171 NPL3037172 NPL3037173 NPL3037174 NPL3037176 NPL3037177 NPL3037178 NPL3037179 NPL3037180 NPL3037181 NPL3037183 NPL3037186 NPL3037188 NPL3037189 NPL3037191 NPL3037194 NPL3037198 NPL3037201 NPL3037203 NPL3037205 NPL3037208 NPL3037211 NPL3037212 NPL3037213 NPL3037215 NPL3037216 NPL3037217 NPL3037219 NPL3037221 NPL3037224 NPL3037225 NPL3037228 NPL3037229 NPL3037230 NPL3037231 NPL3037233 NPL3037237 NPL3037239 NPL3037240 NPL3037241 NPL3037243 NPL3037244 NPL3037246 NPL3037248 NPL3037250 NPL3037251 NPL3037252 NPL3037253 NPL3037254 NPL3037256 NPL3037260 NPL3037262 NPL3037264 NPL3037265 NPL3037266 NPL3037267 NPL3037269 NPL3037270 NPL3037271 NPL3037272 NPL3037277 NPL3037278 NPL3037280 NPL3037281 NPL3037283 NPL3037284 NPL3037285 NPL3037289 NPL3037292 NPL3037293 NPL3037294 NPL3037295 NPL3037297 NPL3037303 NPL3037305 NPL3037306 NPL3037308 NPL3037311 NPL3037319 NPL3037323 NPL3037324 NPL3037326 NPL3037327 NPL3037328 NPL3037329 NPL3037330 NPL3037331 NPL3037334 NPL3037336 NPL3037337 NPL3037340 NPL3037344 NPL3037346 NPL3037349 NPL3037352 NPL3037353 NPL3037355 NPL3037361 NPL3037362 NPL3037363 NPL3037364 NPL3037365 NPL3037366 NPL3037368 NPL3037369 NPL3037370 NPL3037371 NPL3037380 NPL3037381 NPL3037382 NPL3037383 NPL3037384 NPL3037387 NPL3037388 NPL3037389 NPL3037391 NPL3037396 NPL3037397 NPL3037399 NPL3037400 NPL3037402 NPL3037403 NPL3037404 NPL3037405 NPL3037406 NPL3037408 NPL3037411 NPL3037412 NPL3037414 NPL3037418 NPL3037420 NPL3037421 NPL3037425 NPL3037426 NPL3037429 NPL3037430 NPL3037431 NPL3037432 NPL3037433 NPL3037436 NPL3037440 NPL3037441 NPL3037444 NPL3037445 NPL3037446 NPL3037451 NPL3037456 NPL3037457 NPL3037459 NPL3037460 NPL3037462 NPL3037465 NPL3037466 NPL3037469 NPL3037476 NPL3037491 NPL3037493 NPL3037495 NPL3037499 NPL3037501 NPL3037503 NPL3037520 NPL3037526 NPL3037528 NPL3037530 NPL3037531 NPL3037542 NPL3037559 NPL3037563 NPL3037567 NPL3037568 NPL3037569 NPL3037571 NPL3037581 NPL3037586 NPL3037594 NPL3037596 NPL3037598 NPL3037601 NPL3037602 NPL3037603 NPL3037604 NPL3037607 NPL3037611 NPL3037614 NPL3037616 NPL3037617 NPL3037618 NPL3037620 NPL3037621 NPL3037624 NPL3037628 NPL3037629 NPL3037630 NPL3037631 NPL3037634 NPL3037635 NPL3037636 NPL3037637 NPL3037640 NPL3037641 NPL3037642 NPL3037645 NPL3037646 NPL3037647 NPL3037648 NPL3037650 NPL3037651 NPL3037652 NPL3037653 NPL3037654 NPL3037655 NPL3037657 NPL3037658 NPL3037659 NPL3037660 NPL3037661 NPL3037662 NPL3037664 NPL3037668 NPL3037669 NPL3037670 NPL3037672 NPL3037673 NPL3037674 NPL3037677 NPL3037678 NPL3037679 NPL3037681 NPL3037684 NPL3037688 NPL3037689 NPL3037690 NPL3037691 NPL3037695 NPL3037699 NPL3037700 NPL3037703 NPL3037704 NPL3037705 NPL3037706 NPL3037707 NPL3037708 NPL3037711 NPL3037713 NPL3037714 NPL3037715 NPL3037719 NPL3037720 NPL3037725 NPL3037728 NPL3037729 NPL3037732 NPL3037736 NPL3037737 NPL3037740 NPL3037741 NPL3037742 NPL3037745 NPL3037746 NPL3037747 NPL3037748 NPL3037750 NPL3037757 NPL3037759 NPL3037761 NPL3037762 NPL3037764 NPL3037765 NPL3037766 NPL3037767 NPL3037768 NPL3037771 NPL3037774 NPL3037776 NPL3037779 NPL3037780 NPL3037784 NPL3037785 NPL3037786 NPL3037789 NPL3037793 NPL3037796 NPL3037800 NPL3037802 NPL3037805 NPL3037811 NPL3037813 NPL3037814 NPL3037817 NPL3037818 NPL3037823 NPL3037826 NPL3037828 NPL3037830 NPL3037832 NPL3037833 NPL3037835 NPL3037837 NPL3037839 NPL3037842 NPL3037843 NPL3037844 NPL3037845 NPL3037847 NPL3037849 NPL3037850 NPL3037852 NPL3037855 NPL3037858 NPL3037860 NPL3037865 NPL3037870 NPL3037872 NPL3037879 NPL3037883 NPL3037884 NPL3037889 NPL3037899 NPL3037902 NPL3037907 NPL3037909 NPL3037912 NPL3037914 NPL3037915 NPL3037917 NPL3037922 NPL3037925 NPL3037928 NPL3037929 NPL3037930 NPL3037931 NPL3037932 NPL3037934 NPL3037937 NPL3037939 NPL3037944 NPL3037946 NPL3037948 NPL3037954 NPL3037956 NPL3037958 NPL3037960 NPL3037963 NPL3037965 NPL3037966 NPL3037973 NPL3037974 NPL3037975 NPL3037976 NPL3037977 NPL3037978 NPL3037979 NPL3037986 NPL3037990 NPL3037992 NPL3037996 NPL3037999 NPL3038000 NPL3038005 NPL3038012 NPL3038014 NPL3038015 NPL3038019 NPL3038020 NPL3038041 NPL3038042 NPL3038044 NPL3038045 NPL3038046 NPL3038048 NPL3038049 NPL3038051 NPL3038060 NPL3038062 NPL3038063 NPL3038064 NPL3038067 NPL3038069 NPL3038071 NPL3038072 NPL3038074 NPL3038075 NPL3038077 NPL3038078 NPL3038079 NPL3038080 NPL3038081 NPL3038091 NPL3038093 NPL3038097 NPL3038100 NPL3038107 NPL3038108 NPL3038109 NPL3038110 NPL3038113 NPL3038115 NPL3038119 NPL3038125 NPL3038126 NPL3038128 NPL3038129 NPL3038130 NPL3038133 NPL3038134 NPL3038136 NPL3038137 NPL3038138 NPL3038140 NPL3038142 NPL3038143 NPL3038151 NPL3038153 NPL3038154 NPL3038156 NPL3038160 NPL3038161 NPL3038162 NPL3038164 NPL3038167 NPL3038170 NPL3038173 NPL3038174 NPL3038175 NPL3038176 NPL3038177 NPL3038179 NPL3038180 NPL3038181 NPL3038184 NPL3038186 NPL3038187 NPL3038188 NPL3038189 NPL3038191 NPL3038193 NPL3038199 NPL3038205 NPL3038206 NPL3038214 NPL3038215 NPL3038217 NPL3038221 NPL3038222 NPL3038223 NPL3038224 NPL3038227 NPL3038229 NPL3038232 NPL3038233 NPL3038234 NPL3038239 NPL3038240 NPL3038243 NPL3038245 NPL3038246 NPL3038249 NPL3038251 NPL3038252 NPL3038253 NPL3038255 NPL3038256 NPL3038257 NPL3038260 NPL3038261 NPL3038263 NPL3038264 NPL3038265 NPL3038266 NPL3038269 NPL3038274 NPL3038276 NPL3038277 NPL3038280 NPL3038282 NPL3038283 NPL3038286 NPL3038287 NPL3038288 NPL3038291 NPL3038292 NPL3038293 NPL3038296 NPL3038297 NPL3038298 NPL3038300 NPL3038310 NPL3038316 NPL3038319 NPL3038320 NPL3038321 NPL3038323 NPL3038324 NPL3038325 NPL3038326 NPL3038327 NPL3038331 NPL3038334 NPL3038337 NPL3038343 NPL3038344 NPL3038346 NPL3038347 NPL3038348 NPL3038349 NPL3038350 NPL3038352 NPL3038355 NPL3038356 NPL3038361 NPL3038363 NPL3038365 NPL3038366 NPL3038370 NPL3038371 NPL3038372 NPL3038373 NPL3038374 NPL3038375 NPL3038376 NPL3038379 NPL3038380 NPL3038381 NPL3038385 NPL3038386 NPL3038388 NPL3038390 NPL3038395 NPL3038397 NPL3038399 NPL3038400 NPL3038401 NPL3038402 NPL3038403 NPL3038404 NPL3038405 NPL3038409 NPL3038412 NPL3038413 NPL3038414 NPL3038416 NPL3038418 NPL3038419 NPL3038421 NPL3038423 NPL3038427 NPL3038429 NPL3038430 NPL3038432 NPL3038434 NPL3038440 NPL3038443 NPL3038445 NPL3038446 NPL3038461 NPL3038462 NPL3038475 NPL3038494 NPL3038495 NPL3038496 NPL3038497 NPL3038509 NPL3038510 NPL3038512 NPL3038513 NPL3038514 NPL3038515 NPL3038516 NPL3038517 NPL3038518 NPL3038519 NPL3038520 NPL3038522 NPL3038524 NPL3038526 NPL3038527 NPL3038528 NPL3038530 NPL3038532 NPL3038534 NPL3038539 NPL3038545 NPL3038550 NPL3038553 NPL3038580 NPL3038581 NPL3038585 NPL3038588 NPL3038599 NPL3038603 NPL3038604 NPL3038614 NPL3038617 NPL3038630 NPL3038714 NPL3038718 NPL3038719 NPL3038736 NPL3038737 NPL3038738 NPL3038741 NPL3038742 NPL3038779 NPL3038780 NPL3038781 NPL3038802 NPL3038804 NPL3038827 NPL3038828 NPL3038829 NPL3038830 NPL3038831 NPL3038832 NPL3038833 NPL3038847 NPL3038849 NPL3038851 NPL3038852 NPL3038854 NPL3038856 NPL3038865 NPL3038873 NPL3038875 NPL3038876 NPL3038877 NPL3038885 NPL3038888 NPL3038891 NPL3038892 NPL3038895 NPL3038898 NPL3038899 NPL3038900 NPL3038905 NPL3038908 NPL3038909 NPL3038911 NPL3038916 NPL3038917 NPL3038918 NPL3038920 NPL3038921 NPL3038928 NPL3038946 NPL3038947 NPL3038951 NPL3038953 NPL3038954 NPL3038955 NPL3038956 NPL3038958 NPL3038959 NPL3038966 NPL3038972 NPL3038973 NPL3038974 NPL3038975 NPL3038976 NPL3038982 NPL3038984 NPL3038985 NPL3038987 NPL3038989 NPL3038990 NPL3038992 NPL3038996 NPL3039002 NPL3039003 NPL3039012 NPL3039013 NPL3039014 NPL3039015 NPL3039016 NPL3039019 NPL3039020 NPL3039022 NPL3039023 NPL3039024 NPL3039025 NPL3039028 NPL3039033 NPL3039034 NPL3039035 NPL3039036 NPL3039040 NPL3039043 NPL3039044 NPL3039046 NPL3039047 NPL3039055 NPL3039058 NPL3039059 NPL3039060 NPL3039061 NPL3039062 NPL3039063 NPL3039067 NPL3039071 NPL3039072 NPL3039073 NPL3039074 NPL3039076 NPL3039084 NPL3039085 NPL3039087 NPL3039088 NPL3039097 NPL3039119 NPL3039121 NPL3039123 NPL3039127 NPL3039131 NPL3039132 NPL3039134 NPL3039137 NPL3039138 NPL3039152 NPL3039154 NPL3039168 NPL3039179 NPL3039182 NPL3039183 NPL3039187 NPL3039188 NPL3039189 NPL3039190 NPL3039194 NPL3039195 NPL3039201 NPL3039209 NPL3039211 NPL3039212 NPL3039231 NPL3039232 NPL3039233 NPL3039234 NPL3039237 NPL3039239 NPL3039240 NPL3039241 NPL3039242 NPL3039244 NPL3039245 NPL3039246 NPL3039252 NPL3039254 NPL3039255 NPL3039257 NPL3039260 NPL3039262 NPL3039263 NPL3039265 NPL3039266 NPL3039267 NPL3039268 NPL3039269 NPL3039270 NPL3039271 NPL3039272 NPL3039273 NPL3039274 NPL3039278 NPL3039279 NPL3039280 NPL3039291 NPL3039292 NPL3039293 NPL3039296 NPL3039305 NPL3039308 NPL3039309 NPL3039310 NPL3039326 NPL3039327 NPL3039329 NPL3039330 NPL3039331 NPL3039332 NPL3039333 NPL3039334 NPL3039335 NPL3039340 NPL3039345 NPL3039346 NPL3039347 NPL3039348 NPL3039349 NPL3039353 NPL3039354 NPL3039356 NPL3039357 NPL3039359 NPL3039360 NPL3039364 NPL3039365 NPL3039374 NPL3039375 NPL3039376 NPL3039378 NPL3039382 NPL3039383 NPL3039384 NPL3039385 NPL3039386 NPL3039387 NPL3039388 NPL3039389 NPL3039390 NPL3039391 NPL3039392 NPL3039393 NPL3039394 NPL3039395 NPL3039396 NPL3039397 NPL3039398 NPL3039399 NPL3039400 NPL3039401 NPL3039402 NPL3039403 NPL3039404 NPL3039405 NPL3039406 NPL3039407 NPL3039408 NPL3039419 NPL3039420 NPL3039429 NPL3039430 NPL3039435 NPL3039436 NPL3039440 NPL3039456 NPL3039457 NPL3039460 NPL3039479 NPL3039484 NPL3039485 NPL3039486 NPL3039488 NPL3039489 NPL3039490 NPL3039495 NPL3039496 NPL3039497 NPL3039498 NPL3039501 NPL3039504 NPL3039509 NPL3039510 NPL3039511 NPL3039512 NPL3039513 NPL3039514 NPL3039515 NPL3039516 NPL3039517 NPL3039518 NPL3039519 NPL3039523 NPL3039525 NPL3039526 NPL3039528 NPL3039530 NPL3039537 NPL3039542 NPL3039543 NPL3039544 NPL3039545 NPL3039548 NPL3039555 NPL3039556 NPL3039557 NPL3039558 NPL3039560 NPL3039562 NPL3039611 NPL3039612 NPL3039613 NPL3039614 NPL3039615 NPL3039619 NPL3039622 NPL3039625 NPL3039626 NPL3039627 NPL3039640 NPL3039642 NPL3039647 NPL3039656 NPL3039657 NPL3039659 NPL3039660 NPL3039664 NPL3039672 NPL3039678 NPL3039679 NPL3039680 NPL3039681 NPL3039686 NPL3039688 NPL3039701 NPL3039703 NPL3039704 NPL3039705 NPL3039709 NPL3039713 NPL3039732 NPL3039735 NPL3039736 NPL3039776 NPL3039801 NPL3039806 NPL3039844 NPL3039850 NPL3039852 NPL3039862 NPL3039865 NPL3039866 NPL3026119 NPL3026156 NPL3038531 NPL3025012 NPL3026130

What the firm is doing

An URGENT: MEDICAL DEVICE CORRECTION notification letter dated November 2024 was sent to customers. Actions Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Additional Information Medtronic is actively working on a permanent solution and will inform you as soon as it becomes available. Medtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and the FDA MedWatch Adverse Event Reporting program via: Medtronic email at RS.NeuAdverseEventReporting@Medtronic.com or Medtronic Technical Services at 1-800-707-0933 weekdays 7:00 AM 6:00 PM CT. ***Update January 2026*** An URGENT: MEDICAL DEVICE CORRECTION notification letter dated January 2026 was sent to customers. The purpose of this letter is to inform you that a new version of the Model A810 SynchroMed Clinician Programmer Application (CP App), v2.0.3320, is now available for installation. This update addresses previously communicated software issues associated with earlier versions used for the Model 8637 SynchroMed II and Model 8667 SynchroMed III infusion pumps. These issues were initially communicated to you in the letter enclosed from November 2024. The new version of the A810 CP App resolves these issues. Customer Actions: " Download and install A810 CP App v2.0.3320 at your earliest convenience and contact your local Medtronic representative if you have any questions related to the update. " Sign and return the Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Retain a copy of this lette

DistributionShow details

Worldwide - US Nationwide distribution.

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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