Spark Biomedical Inc recalls 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

Recalled August 20, 2025 · FDA recall Z-2287-2025 · Spark Biomedical

Hazard

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

Units

78 units

Sold at

US Nationwide distribution.

Description

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

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

Manufacturer(s)

Spark Biomedical Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →