Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model: B35200; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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.govFDA Recall Number: Z-1129-2022
Related Recalls
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medtronic Neuromodulation
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Medtronic Neuromodulation
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Medtronic Neuromodulation
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.