Reported Apr 16, 2025 · Ongoing
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
- Lot codes and dates
- UDI-DI00763000371463
- Serial Numbers
1,493 of 1,493 codes
NPL1000037NPL1000042NPL1000053NPL1000055NPL1000056NPL1000062NPL1000067NPL1000069NPL1000072NPL1000073NPL1000074NPL1000075NPL1000076NPL1000098NPL1000135NPL1000137NPL1000138NPL1000151NPL1000160NPL1000161NPL1000165NPL1000173NPL1000174NPL1000175NPL1000179NPL1000180NPL1000185NPL1000186NPL1000188NPL1000189NPL1000191NPL1000195NPL1000230NPL1000238NPL1000242NPL1000244NPL1000245NPL1000246NPL1000248NPL1000249NPL1000252NPL1000281NPL1000292NPL1000295NPL1000297NPL1000301NPL1000303NPL1000304NPL1000305NPL1000323NPL1000325NPL1000331NPL1000344NPL1000361NPL1000363NPL1000364NPL1000365NPL1000370NPL1000429NPL1000435
- Amount recalled
- 1493 devices
Where it was sold
- Nationwide
- PR
Why it was recalled
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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