Recall Z-0206-2025 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
| Date | Oct 23, 2024 (initiated Sep 24, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Medtronic neuromodulation issued an URGENT MEDICAL DEVICE RECALL notice to its consignees of 09/24/2024 via letter. The notice explained the issue, potential risk, and requested the affected devices in stock be returned. The notice is to be shared with those to whom the device was distributed. If the device has been implanted, the consignee was directed to contact their Medtronic Representative to determine if there are additional steps that may establish communication with the INS. On 07-Oct-24 and 08-Oct-24, a Medtronic representative successfully performed an update using a manufac |
| Quantity | 39 units |
| Distribution | International distribution to the countries of Germany, UK, and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.