FDA Device recall Z-2287-2025
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
- FDA Device
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of 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 by Spark Biomedical, citing due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2287-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-02 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Spark Biomedical |
| Distribution | US |
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
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Identifiers
| code_info | Lot numbers: V2408xxxx and runs through V2519xxxx UDI: 11-110/00850052017033; 11-310-K/00860005396948; 11-320-K/0086000…Lot numbers: V2408xxxx and runs through V2519xxxx UDI: 11-110/00850052017033; 11-310-K/00860005396948; 11-320-K/00860005396986; 11-321-K/00850052017163; 11-310-K-28/00850052017088; 11-320-K-28/00850052017071; 11-321-K-28/00850052017170 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2287-2025%22
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