Recall Z-2287-2025— Spark Biomedical Inc
Class II · Ongoing
Class II FDA medical device recall by Spark Biomedical Inc, initiated 2025-07-02. It names one FDA 510(k) clearance: K230796. 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: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output..
- Recalling firm
- Spark Biomedical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-02
- Firm location
- Richmond, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.