FDA Enforcement
Class II
Ongoing
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: Z-2287-2025
·
Reported August 20, 2025
Enforcement
- Recall Number
- Z-2287-2025
- Event ID
- 97185
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Spark Biomedical Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- August 20, 2025
- Initiation Date
- July 2, 2025
- Classification Date
- August 11, 2025
- Address
- 19830 Fm 1093 Rd Ste 401, N/A, Richmond, TX, 77407-8621, United States
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
Reason
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Code Info
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
Distribution
US Nationwide distribution.
Quantity
78 units