[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 — Due to manufacturing issue, neurostimulator device may experience "cable discon… | FDA 2025-07-02
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Spark Biomedical Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2287-2025 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 02 July 2025 |
| EAN / barcode | 00850052017033 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.