Recall archive / FDA device enforcement
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. — FDA record Z-0206-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 24, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 39 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0206-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of Germany, UK, and Israel.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 30, 2024
- Recall initiation date
- Sep 24, 2024
- Center classification date
- Oct 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.