Spark Biomedical Inc recalls Sparrow Ascent Patient Controller

Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-2287-2025
• FDA 510(k) clearance · K230796The device's official FDA premarket clearance record
• FDA device classification · PZROfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.5896The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Spark Biomedical IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.