Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Enhanced Verify Evaluation Handset (CFN HH90130FA) Recalled by Medtronic Neuromodulation Due to Evaluation handsets may not be able to communicate...

Date: April 3, 2025
Company: Medtronic Neuromodulation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.

Affected Products

Enhanced Verify Evaluation Handset (CFN HH90130FA)

Quantity: 534

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Neuromodulation

Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report