Percept PC BrainSense recallZ-1129-2022 · Medtronic Neuromodulation · initiated Mar 30, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1129-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 30, 2022
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1 unit
- Product code
- MRU
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Product description
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Code information (models, lots, serial numbers)
Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · Deep brain stimulator for obsessive compulsive disorder (OCD)4 recalls1 death547 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 89994).
- Z-1128-2022 · Open, ClassifiedPercept BrainSense Implantable Neurostimulator (INS), Model B35200
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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