Percept PC BrainSense Implantable Neurostimulator Recalled for Communication Failure
Medtronic has recalled the Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication failures with programmer systems. The device cannot reliably communicate with clinical or patient programmer systems.
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 is an FDA Class II medical device recall for an implantable neurostimulator with a communication malfunction. Although no illnesses or injuries have been reported, the loss of communication with programmer systems represents a risk of harm to patients, meeting the criteria for High severity.
Plain-English summary
Medtronic Neuromodulation is recalling the Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200. The implanted device cannot communicate with the clinical programmer system and/or the patient programmer system.
The recall affects implants distributed worldwide, including throughout the United States and multiple countries. The affected device is Model B35200 with GTIN/UPN 00763000420987.
Patients with this implant should consult with their healthcare provider regarding this recall and any necessary actions.
The recalled product
- Product
- Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- communication-failure
- device-malfunction
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 (4)
- Model: B35200
- GTIN/UPN: 00763000420987
- Serial number: NPI708734H
- Expiration Date: 10/28/2022
Distribution
Distributed nationwide across the United States.
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