Medtronic Neuromodulation Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
Model: B35200, GTIN/UPN: 00763000420987, Serial number: NPI708734H, Expiration Date: 10/28/2022
Products Sold
Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
Medtronic Neuromodulation is recalling Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 due to The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Recommended Action
Per FDA guidance
A customer letter, dated March 2022, was issued to the impacted consignee via mail. The consignee is instructed to ensure the patient programmer system is set up to communicate with the patient's INS at the patient's initial programming session. If a patient's INS cannot communicate with the clinician programmer and/or patient programmer system, and it is not possible to make therapy adjustments or turn stimulation off, the consignee should contact Medtronic Technical Services at 1-800-707-0933. The consignee is also asked to complete the customer confirmation form and submit to the recalling firm.
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