FDA recall Z-2287-2025

Spark Biomedical Inc · Class II · 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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-07-02
Report date
2025-08-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Richmond, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2287-2025