Recall Z-0206-2025— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2024-09-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.. Reason: A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-09-24
- Firm location
- Minneapolis, MN, United States
Product description
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Reason for recall
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
Data sourced from openFDA. This site is unofficial and independent of the FDA.