Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sparrow Ascent Patient Controller Recalled by Spark Biomedical Inc Due to Due to manufacturing issue, neurostimulator device may experience...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Spark Biomedical Inc directly.
Affected 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
Quantity: 78 units
Why Was This Recalled?
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Spark Biomedical Inc
Spark Biomedical Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report