Sparrow Ascent Patient Controller (Spark Biomedical) – Cable Disconnect (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Spark Biomedical Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Spark Biomedical Inc is recalling Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-32 due to Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026