Spark Biomedical Inc: Device Recall
Recall #Z-2287-2025 · 07/02/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2287-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Spark Biomedical Inc
- Status
- Ongoing
- Date Initiated
- 07/02/2025
- Location
- Richmond, TX, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 78 units
Reason for Recall
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Product Description
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
Distribution Pattern
US Nationwide distribution.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.