FDA-Device2025-05-07Class II
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medtronic Neuromodulation
Hazard
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.
Sold states
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.
Affected count
534
Manufactured in
7000 Central Ave Ne, N/A, Minneapolis, MN, United States
Products
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1704-2025Don't want to check this manually?
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