Sparrow Ascent Patient Controller — Class II medical device recall Z-2287-2025
Ongoing recall by Spark Biomedical Inc, reported 2025-08-20, distributed nationwide. Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interru
| Recall number | Z-2287-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spark Biomedical Inc, Richmond, TX, United States |
| Recall initiated | 2025-07-02 |
| Classified | 2025-08-11 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 78 units |
| UPC / GTIN / UDI-DI | 00850052017033, 00850052017071, 00850052017088, 00850052017163, 00850052017170, 00860005396948, 00860005396986 |
| Lot numbers | V2408XXXX |
| Model numbers | 11-110-K, 11-310-K, 11-310-K-28, 11-320-K, 11-320-K-28, 11-321-K, 11-321-K-28 |
Product
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28
Reason for recall
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
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-2287-2025. 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.