Recall Z-1129-2022— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2022-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200. Reason: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-30
- Firm location
- Minneapolis, MN, United States
Product description
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Reason for recall
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Data sourced from openFDA. This site is unofficial and independent of the FDA.