Medical Device Recall: Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medtronic Neuromodulation · April 3, 2025
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
534
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1704-2025
Status: ongoing
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