The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1129-2022·Announced 2022-06-01

Percept PC BrainSense Implantable Neurostimulator Recalled for Communication Failure

Medtronic has recalled the Percept PC BrainSense Implantable Neurostimulator Model B35200 due to communication failures with programmer systems. The device cannot reliably communicate with clinical or patient programmer systems.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for an implantable neurostimulator with a communication malfunction. Although no illnesses or injuries have been reported, the loss of communication with programmer systems represents a risk of harm to patients, meeting the criteria for High severity.

Plain-English summary

Medtronic Neuromodulation is recalling the Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200. The implanted device cannot communicate with the clinical programmer system and/or the patient programmer system.

The recall affects implants distributed worldwide, including throughout the United States and multiple countries. The affected device is Model B35200 with GTIN/UPN 00763000420987.

Patients with this implant should consult with their healthcare provider regarding this recall and any necessary actions.

The recalled product

Product
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Manufacturer
Medtronic Neuromodulation
Category
Medical Device — Implantable Neurostimulator
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Neuromodulation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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