Class II

Medical Device Recall: 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

Spark Biomedical Inc · July 2, 2025

Reason for Recall

Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

78 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2287-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Spark Biomedical Inc Medical Device Recall: 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 | SafeCheck