Sparrow Ascent Patient Controller recall
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
Why was Sparrow Ascent Patient Controller recalled?
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: V2408xxxx and runs through V2519xxxx UDI: 11-110/00850052017033; 11-310-K/00860005396948; 11-320-K/00860005396986; 11-321-K/00850052017163; 11-310-K-28/00850052017088; 11-320-K-28/00850052017071; 11-321-K-28/00850052017170
- 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
- Recalling firm
- Spark Biomedical Inc
- Quantity
- 78 units
- Distribution
- US Nationwide distribution.
- Recall date
- August 20, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)