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
Reported: August 20, 2025 Initiated: July 2, 2025 #Z-2287-2025
Product Description
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.
Details
- Recalling Firm
- Spark Biomedical Inc
- Units Affected
- 78 units
- Distribution
- US Nationwide distribution.
- Location
- Richmond, TX
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Spark Biomedical Inc. Units affected: 78 units.
Why was this product recalled? ▼
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 20, 2025. Severity: Moderate. Recall number: Z-2287-2025.
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