FDAJuly 2, 2025device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
What to do
FDA enforcement status: Ongoing
Brands named
spark biomedicalspark
UPCs
00850052017033008600053969480086000539698600850052017163008500520170880085005201707100850052017170
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Ac...2025-05-21
- FDACenterline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter2025-04-11
- FDAStatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription use blood glucose ketone meter for near-patient testing2024-11-20
- FDAStatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use blood glucose meter for near-patient testing.2024-11-20
- FDAStatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910. Prescription use blood glucose ketone meter for near-patient testing2024-11-20
- FDATriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)2024-11-11
- FDAPower Express, REF B909182024-07-17
- FDAPE Centrifuge, REF: B36365, a component of the Power Express2024-07-17
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