FDAHealthJuly 2, 2025
Spark Biomedical Inc — 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
⚠️ Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 2, 2025
US Nationwide distribution.
What's affected?
- 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
- Brand
- Spark Biomedical Inc
- Lot code
- V2408xxxx
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 78 units.
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