Official recall record
Enhanced Verify Evaluation Handset (CFN HH90130FA)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-04-03
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00763000930042
- Brand on record
- Medtronic Neuromodulation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-04-08 · US FDA — Medical Devices
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the follow - 2025-11-20 · US FDA — Medical Devices
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A
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