Medtronic Percept BrainSense Neurostimulator Cannot Communicate with Programmer Systems
Medtronic is recalling 14,164 Percept BrainSense Implantable Neurostimulators (Model B35200) worldwide because the devices cannot communicate with clinical or patient programmer systems, preventing proper device monitoring and adjustment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a risk-of-harm product (an implanted neurostimulator) with a functional communication defect. The source text reports no illnesses, injuries, hospitalizations, or adverse events. The FDA classified this as Class II. The inability to communicate with programmer systems poses potential risks to device management and patient care, but no actual harm is documented in the source.
Plain-English summary
Medtronic Neuromodulation is recalling 14,164 units of the Percept BrainSense Implantable Neurostimulator (INS), Model B35200. The recalled devices have a defect that prevents them from communicating with the clinical programmer and/or patient programmer system.
Because the devices cannot communicate with programmer systems, healthcare providers may be unable to monitor device function or adjust therapy settings. Patients with these devices should contact their healthcare provider to determine whether their device is affected and to discuss appropriate follow-up care.
The affected devices were distributed worldwide, including throughout the United States and multiple other countries. The recall involves devices with serial numbers in the NPI702-NPI707 series, with expiration dates ranging from November 14, 2021 through February 14, 2024.
The recalled product
- Product
- Percept BrainSense Implantable Neurostimulator (INS), Model B35200
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- communication-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model: B35200
- Expiration Range: 11/14/2021-02/14/2024
- GTIN/UPN: 00763000253363
- Serial Numbers: NPI702363H
- NPI702456H
- NPI702503H
- NPI702504H
- NPI702543H
- NPI702551H
- NPI702575H
- NPI703408H
- NPI703516H
- NPI703553H
- NPI703635H
- NPI703969H
- NPI703972H
- NPI704070H
- NPI704084H
- NPI704097H
- NPI704103H
Distribution
Distributed nationwide across the United States.
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