Percept RC Neurostimulator (Medtronic) – Programming Compatibility (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
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
Products Sold
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
Medtronic Neuromodulation is recalling Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300. due to A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026