August 20, 2025Medical DevicesFDA
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
Hazard: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.