Recall Z-2287-2025 ยท PZR Percutaneous Nerve Stimulator For Opioid Withdrawal
Spark Biomedical Inc
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
| Date | Aug 11, 2025 (initiated Jul 2, 2025) |
| Status | Open, Classified |
| Reason | Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 78 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K230796 | Sparrow Ascent Spark Biomedical, Inc., Jun 20, 2023 |