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RecallWatchMedical Device Safety
Class IIOngoingZ-1543-2025

Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application

Medtronic NeuromodulationMinneapolis, MN, United StatesReported Apr 16, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

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.

Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators

Lot / code information

UDI
00763000371463
Serial #
NPL1000037 NPL1000042 NPL1000053 NPL1000055 NPL1000056 NPL1000062 NPL1000067 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000076 NPL1000098 NPL1000135 NPL1000137 NPL1000138 NPL1000151 NP…Show all
NPL1000037 NPL1000042 NPL1000053 NPL1000055 NPL1000056 NPL1000062 NPL1000067 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000076 NPL1000098 NPL1000135 NPL1000137 NPL1000138 NPL1000151 NPL1000160 NPL1000161 NPL1000165 NPL1000173 NPL1000174 NPL1000175 NPL1000179 NPL1000180 NPL1000185 NPL1000186 NPL1000188 NPL1000189 NPL1000191 NPL1000195 NPL1000230 NPL1000238 NPL1000242 NPL1000244 NPL1000245 NPL1000246 NPL1000248 NPL1000249 NPL1000252 NPL1000281 NPL1000292 NPL1000295 NPL1000297 NPL1000301 NPL1000303 NPL1000304 NPL1000305 NPL1000323 NPL1000325 NPL1000331 NPL1000344 NPL1000361 NPL1000363 NPL1000364 NPL1000365 NPL1000370 NPL1000429 NPL1000435 NPL1000443 NPL1000446 NPL1000447 NPL1000453 NPL1000486 NPL1000502 NPL1000504 NPL1000505 NPL1000506 NPL1000507 NPL1000509 NPL1000510 NPL1000514 NPL1000516 NPL1000518 NPL1000519 NPL1000528 NPL1000533 NPL1000555 NPL1000558 NPL1000561 NPL1000562 NPL1000575 NPL1000584 NPL1000585 NPL1000592 NPL1000603 NPL1000606 NPL1000612 NPL1000631 NPL1000634 NPL1000638 NPL1000639 NPL1000652 NPL1000653 NPL1000657 NPL1000776 NPL1000794 NPL1000814 NPL1000815 NPL1000817 NPL1000819 NPL1000834 NPL1000835 NPL1001212 NPL1001236 NPL1001241 NPL1001245 NPL1001246 NPL1001265 NPL1001273 NPL1001282 NPL1001301 NPL1001332 NPL1001339 NPL1001353 NPL1001354 NPL1001364 NPL1001369 NPL1001371 NPL1001389 NPL1001429 NPL1001434 NPL1001435 NPL1001436 NPL1001449 NPL1001464 NPL1001506 NPL1001507 NPL1001512 NPL1001520 NPL1001542 NPL1001549 NPL1001558 NPL1001588 NPL1001591 NPL1001592 NPL1001608 NPL1001647 NPL1001650 NPL1001670 NPL1001678 NPL1001694 NPL1001695 NPL1001697 NPL1001700 NPL1001702 NPL1001705 NPL1001707 NPL1001708 NPL1001709 NPL1001710 NPL1001711 NPL1001716 NPL1001717 NPL1001727 NPL1001728 NPL1001756 NPL1001759 NPL1001763 NPL1001764 NPL1001765 NPL1001769 NPL1001773 NPL1001789 NPL1001797 NPL1001798 NPL1001800 NPL1001801 NPL1001804 NPL1001811 NPL1001812 NPL1001815 NPL1001816 NPL1001817 NPL1001823 NPL1001824 NPL1001825 NPL1001841 NPL1001847 NPL1001881 NPL1001882 NPL1001884 NPL1001889 NPL1001896 NPL1001933 NPL1001947 NPL1001963 NPL1002004 NPL1002007 NPL1002018 NPL1002064 NPL1002088 NPL1002089 NPL1002091 NPL1002092 NPL1002200 NPL1002214 NPL1002226 NPL1002227 NPL1002232 NPL1002250 NPL1002284 NPL1002288 NPL1002295 NPL1002307 NPL1002309 NPL1002310 NPL1002327 NPL1002330 NPL1002340 NPL1002341 NPL1002347 NPL1002362 NPL1002363 NPL1002369 NPL1002380 NPL1002382 NPL1002410 NPL1002428 NPL1002433 NPL1002438 NPL1002440 NPL1002443 NPL1002445 NPL1002467 NPL1002470 NPL1002503 NPL1002505 NPL1002508 NPL1002540 NPL1002544 NPL1002545 NPL1002548 NPL1002555 NPL1002556 NPL1002568 NPL1002572 NPL1002592 NPL1002618 NPL1002637 NPL1002639 NPL1002640 NPL1002648 NPL1002649 NPL1002656 NPL1002665 NPL1002666 NPL1002672 NPL1002673 NPL1002674 NPL1002690 NPL1002707 NPL1002730 NPL1002756 NPL1002760 NPL1002780 NPL3000005 NPL3000006 NPL3000007 NPL3000009 NPL3000010 NPL3000011 NPL3000016 NPL3000017 NPL3000018 NPL3000023 NPL3000024 NPL3000025 NPL3000026 NPL3000030 NPL3000031 NPL3000035 NPL3000038 NPL3000042 NPL3000043 NPL3000048 NPL3000050 NPL3000055 NPL3000056 NPL3000058 NPL3000059 NPL3000066 NPL3000070 NPL3000075 NPL3000083 NPL3000090 NPL3000094 NPL3000097 NPL3000098 NPL3000109 NPL3000110 NPL3000120 NPL3000125 NPL3000129 NPL3000134 NPL3000135 NPL3000183 NPL3000185 NPL3000186 NPL3000187 NPL3000188 NPL3000191 NPL3000192 NPL3000203 NPL3000208 NPL3000209 NPL3000212 NPL3000215 NPL3000217 NPL3000220 NPL3000221 NPL3000222 NPL3000223 NPL3000231 NPL3000241 NPL3000252 NPL3000253 NPL3000254 NPL3002258 NPL3002260 NPL3002264 NPL3002270 NPL3002272 NPL3002273 NPL3002275 NPL3002278 NPL3002279 NPL3002282 NPL3002283 NPL3002290 NPL3002293 NPL3002297 NPL3002301 NPL3002306 NPL3002307 NPL3002655 NPL3002657 NPL3002660 NPL3002682 NPL3002683 NPL3002710 NPL3002726 NPL3002735 NPL3002744 NPL3002873 NPL3002875 NPL3002877 NPL3002891 NPL3002895 NPL3002897 NPL3002899 NPL3002908 NPL3002910 NPL3002911 NPL3002912 NPL3002919 NPL3002922 NPL3002923 NPL3002925 NPL3002927 NPL3002928 NPL3002932 NPL3002937 NPL3002945 NPL3002954 NPL3002960 NPL3003300 NPL3003307 NPL3003315 NPL3003320 NPL3003338 NPL3003339 NPL3003344 NPL3003353 NPL3003357 NPL3003358 NPL3003549 NPL3003551 NPL3003553 NPL3003557 NPL3003569 NPL3003570 NPL3003700 NPL3003710 NPL3003716 NPL3003717 NPL3003726 NPL3003735 NPL3003741 NPL3003742 NPL3003987 NPL3005006 NPL3005009 NPL3005025 NPL3005843 NPL3006029 NPL3006068 NPL3006072 NPL3006084 NPL3006132 NPL3006238 NPL3006310 NPL3006357 NPL3006367 NPL3006374 NPL3006375 NPL3006377 NPL3006407 NPL3006414 NPL3006452 NPL3006458 NPL3006465 NPL3006469 NPL3006470 NPL3006476 NPL3006482 NPL3006483 NPL3006484 NPL3006485 NPL3006489 NPL3006490 NPL3006494 NPL3006495 NPL3006498 NPL3006518 NPL3006519 NPL3006522 NPL3006525 NPL3006536 NPL3006634 NPL3006911 NPL3006934 NPL3006944 NPL3006951 NPL3006953 NPL3006966 NPL3006967 NPL3006983 NPL3007387 NPL3007392 NPL3007591 NPL3007877 NPL3007892 NPL3007895 NPL3007896 NPL3007897 NPL3007908 NPL3007921 NPL3010632 NPL3010654 NPL3010683 NPL3010764 NPL3010878 NPL3010902 NPL3010904 NPL3010905 NPL3010906 NPL3011113 NPL3011225 NPL3011235 NPL3011236 NPL3011240 NPL3011245 NPL3011246 NPL3011247 NPL3011269 NPL3011297 NPL3011300 NPL3011311 NPL3011314 NPL3011349 NPL3011350 NPL3011362 NPL3011363 NPL3011449 NPL3011452 NPL3011572 NPL3011573 NPL3011600 NPL3011606 NPL3011709 NPL3013655 NPL3013656 NPL3013665 NPL3013669 NPL3013676 NPL3013679 NPL3013683 NPL3013708 NPL3013715 NPL3013721 NPL3013740 NPL3013743 NPL3013746 NPL3013755 NPL3013759 NPL3013782 NPL3013786 NPL3013904 NPL3013913 NPL3013916 NPL3013920 NPL3013967 NPL3013970 NPL3014043 NPL3014064 NPL3014070 NPL3014071 NPL3014073 NPL3014076 NPL3014097 NPL3014098 NPL3014298 NPL3014335 NPL3014345 NPL3014346 NPL3014455 NPL3014456 NPL3014457 NPL3014459 NPL3014500 NPL3014528 NPL3014573 NPL3015558 NPL3016440 NPL3016447 NPL3016476 NPL3016478 NPL3016488 NPL3016506 NPL3016513 NPL3016517 NPL3016606 NPL3016607 NPL3016608 NPL3016610 NPL3016617 NPL3016709 NPL3016710 NPL3016738 NPL3016761 NPL3016776 NPL3016780 NPL3016790 NPL30 …

What the firm is doing

An "URGENT: MEDICAL DEVICE CORRECTION" notification letter dated March 2025 was sent to customers. The letter described the product, problem and actions to be taken. Required Actions: When utilizing any of the lead options mentioned above, avoid using the Switch Device feature to transfer data from the Model A71300 Stimulation Trialing CP App to the Model A71400 Stimulation RC CP App. As an alternative, manually enter the patient and lead information using the Model A71400 Stimulation RC CP App, ensuring not to utilize the Switch Device feature. Inform relevant medical staff about the potential of this issue and the steps to mitigate it. Ensure that backup INS devices are readily available for scheduled surgeries. During the implant procedure, check the system integrity before securing the neurostimulator in place as described in the Inceptiv/Intellis Pro Implant Manual. Please complete and return the customer confirmation form enclosed in this letter acknowledging that you have received this information. Please contact Medtronic Technical Services at 1-800-707-0933 if you have any questions regarding this communication.

DistributionShow details

Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, 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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