Medtronic Neuromodulation: Medical Device Recall in 2022 - (Recall #: Z-1129-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200

Product Classification:

Class II

Date Initiated: March 30, 2022

Date Posted: June 1, 2022

Recall Number: Z-1129-2022

Event ID: 89994

Reason for Recall:

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

Status: Ongoing

Product Quantity: 1 unit

Code Information:

Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated