Recall Z-0206-2025
Medtronic Neuromodulation · initiated September 24, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Codes / lots: GTIN 00763000813468, Serial Numbers: NND504236H, NND504252H; GTIN 00763000813475, Serial Numbers: NND504165H, NND504169H, NND504174H, NND504181H, NND504208H, NND504212H, NND504215H, NND504216H, NND504217H, NND504218H, NND504221H, NND504222H, NND504223H, NND504224H, NND504229H, NND504230H, NND504232H, NND504234H, NND504235H, NND504243H, NND504255H, NND504156H, NND504157H, NND504159H, NND504160H; GTIN 00763000813529, Serial Numbers: NND504167H, NND504178H, NND504179H, NND504180H, NND504182H, NND504227H, NND504228H; GTIN A7630008135201, Serial Numbers: NND504167H, NND504178H, NND504180H; GTIN A7630008134701, Serial Numbers: NND504181H, NND504243H
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 manufacturing software tool to reestablish communication to the affected devices. Consignees were provided a consignee notification regarding this action.
Details
- Recall number
- Z-0206-2025
- Initiated
- September 24, 2024
- Posted by FDA
- October 23, 2024
- Product code
- MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Quantity
- 39 units
- Distribution
- International distribution to the countries of Germany, UK, and Israel.
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN