Z-1129-2022Class II

Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200

Name: Z-1129-2022 Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Creator: Medtronic Neuromodulation
Published: 2022-03-30
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2022-03-30 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200 on 2022-03-30. FDA classified it as Class II and gives the reason as "The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1129-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-30
Posted: 2022-05-24
Recalling firm: Medtronic Neuromodulation
Product: Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Product code: MRU Implanted Subcortical Electrical Stimulator (Motor Disorders)
Reason for recall: The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
FDA 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 in commerce: 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.
Product codes and lots: Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1129-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1128-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-01	2022-05-24
Z-1129-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-01	2022-05-24

Product code MRU

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)