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
FDA device recall Z-2287-2025 · posted 2025-08-11 · Open, Classified
Recall details
- Recalling firm
- Spark Biomedical Inc
- Reason for recall
- Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
- Action taken
- On July 2, 2025, Spark Biomedical initiated a Urgent Medical Device Recall via phone. During the phone conversation, Spark Biomedical will ask consignees to take the following actions: 1. Spark Biomedical will replace all affected00 units at no cost. Even if the units appear to be working. 2. Current devices may continue to be used until they are replaced. 3. Please perform a check of the cable to patient controller connection before use. If this connection is loose or moves, please discontinue use of that patient controller device and quarantine that device until the replacement arrives. 4. Please notify all appropriate personnel at your facility that need to know about this recall.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- PZR
- Quantity affected
- 78 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-07-02
- Date posted
- 2025-08-11
- Location
- Richmond, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sparrow Ascent (K230796) | Spark Biomedical, Inc. | 2023-06-20 |