Enhanced Verify Evaluation Handset (CFN HH90130FA)
Reported: May 7, 2025 Initiated: April 3, 2025 #Z-1704-2025
Product Description
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 534
- 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.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Enhanced Verify Evaluation Handset (CFN HH90130FA). Recalled by Medtronic Neuromodulation. Units affected: 534.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 7, 2025. Severity: Moderate. Recall number: Z-1704-2025.
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