Spark Biomedical Inc recalls 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
- Recall date
- July 2, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2287-2025
- FDA classification
- Class II
- Brand / firm
- Spark Biomedical Inc
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever Spark Biomedical Inc has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Spark Biomedical Inc