Reported Aug 20, 2025 · Ongoing
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.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spark Biomedical Inc · 19830 Fm 1093 Rd Ste 401 · Richmond, TX · 77407-8621
Is this the product you have?
- Sparrow Ascent Patient Controller
- REF's
11-110-K11-310-K11-320-K11-321-K11-310-K-2811-320-K-2811-321-K-28
- Lot codes and dates
7 of 7 products · 7 lot codes
Recalled lot codes, grouped by product number Product number Lot codes and dates 11-11000850052017033
11-310-K00860005396948
11-320-K00860005396986
11-321-K00850052017163
11-310-K-2800850052017088
11-320-K-2800850052017071
11-321-K-2800850052017170
- Amount recalled
- 78 units
Where it was sold
- Nationwide
Why it was recalled
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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