FDA Device recall Z-1543-2025

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

FDA Device
Class II
ongoing
Published 2025-04-16

On 2025-04-16 the FDA classified a Class II recall of Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) n… by Medtronic Neuromodulation, citing there is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1543-2025
Classification	Class II
Status	ongoing
Initiated	2025-03-04
Published	2025-04-16
Last updated	2026-09-13 11:57 UTC
Company	Medtronic Neuromodulation
Distribution	US

Product

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

Reason

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

Identifiers

code_info	UDI-DI: 00763000371463; Serial Numbers: NPL1000037 NPL1000042 NPL1000053 NPL1000055 NPL1000056 NPL1000062 NPL1000067 NP… UDI-DI: 00763000371463; Serial Numbers: 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 NPL

code_info

UDI-DI: 00763000371463; Serial Numbers: NPL1000037 NPL1000042 NPL1000053 NPL1000055 NPL1000056 NPL1000062 NPL1000067 NP…

UDI-DI: 00763000371463; Serial Numbers: 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 NPL

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1543-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.