Medtronic Neuromodulation recalls Enhanced Verify Evaluation Handset (CFN HH90130FA)

Recall date

April 3, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1704-2025

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Enhanced Verify Evaluation Handset (CFN HH90130FA)