Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Reported: October 30, 2024 Initiated: September 24, 2024 #Z-0206-2025
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 39 units
- Distribution
- International distribution to the countries of Germany, UK, and Israel.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.. Recalled by Medtronic Neuromodulation. Units affected: 39 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 30, 2024. Severity: Moderate. Recall number: Z-0206-2025.
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