Enhanced Verify Evaluation Handset — Class II medical device recall Z-1704-2025
Ongoing recall by Medtronic Neuromodulation, reported 2025-05-07, distributed nationwide. Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster pr
| Recall number | Z-1704-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2025-04-03 |
| Classified | 2025-04-30 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 534 |
| UPC / GTIN / UDI-DI | 00763000930042 |
| Lot numbers | NPN0076461, NPN0076462, NPN0076465, NPN0076466, NPN0076467, NPN0076468, NPN0076469, NPN0076470, NPN0076471, NPN0076472, NPN0076473, NPN0076474, NPN0076475, NPN0076476, NPN0076477, NPN0076479, NPN0076480, NPN0076482, NPN0076483, NPN0076485, NPN0076486, NPN0076487, NPN0076488, NPN0076489, NPN0076490, NPN0076491, NPN0076492, NPN0076493, NPN0076494, NPN0076495, NPN0076496, NPN0076497, NPN0076498, NPN0076499, NPN0076500, NPN0076501, NPN0076502, NPN0076504, NPN0076505, NPN0076506 and 460 more |
| Serial numbers | NPN0076461, NPN0076462, NPN0076465, NPN0076466, NPN0076467, NPN0076468, NPN0076469, NPN0076470, NPN0076471, NPN0076472, NPN0076473, NPN0076474, NPN0076475, NPN0076476, NPN0076477, NPN0076479, NPN0076480, NPN0076482, NPN0076483, NPN0076485, NPN0076486, NPN0076487, NPN0076488, NPN0076489, NPN0076490 and 475 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1704-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.