Recall Z-1704-2025— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2025-04-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Enhanced Verify Evaluation Handset (CFN HH90130FA). Reason: 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-04-03
- Firm location
- Minneapolis, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.