[pending] Enhanced Verify Evaluation Handset (CFN HH90130FA)
Pending LLM rewrite. Source: FDA_DEVICE Z-1704-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Enhanced Verify Evaluation Handset (CFN HH90130FA)
- Manufacturer
- Medtronic Neuromodulation
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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