FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
- Recall number
- Z-1129-2022
- Recalling firm
- Medtronic Neuromodulation
- Product
- Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
- Status
- Open, Classified
- Initiated
- 2022-03-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 1 unit
- 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.
- Lot, serial or model codes
- Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MRU
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28