FDA-Device2025-08-20Class II
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
Hazard
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Sold states
US Nationwide distribution.
Affected count
78 units
Manufactured in
19830 Fm 1093 Rd Ste 401, N/A, Richmond, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2287-2025Don't want to check this manually?
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