# FDA recall Z-1704-2025

> **Medtronic Neuromodulation** · Class II · device recall initiated 2025-04-03.

## 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

- **Recall number:** Z-1704-2025
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-03
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1704-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1704-2025. Source: US FDA. Licensed CC0.

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