🔍 RecallPedia

Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200

Class I - Dangerous
🏥 Medical Devices Recalled: March 30, 2022 Medtronic Neuromodulation Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Medtronic Neuromodulation
Reason for Recall:
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1129-2022

Related Recalls

Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump

Medtronic Neuromodulation

Class I - Dangerous

Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.

Apr 8, 2026 Implants & Prosthetics View Details →