Device 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
Z-2287-2025
Product summary
- Event
- Event 97185
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 78 units
- Official record key
device-enforcement:Z-2287-2025
Official wording
Reason: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Code information: 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 pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.