FDA recall Z-1704-2025

Medtronic Neuromodulation · Class II · device

Product

Enhanced Verify Evaluation Handset (CFN HH90130FA)

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.

Key facts

Status
Ongoing
Initiation date
2025-04-03
Report date
2025-05-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1704-2025