Sparrow Ascent Patient Controller, REF's: 11-110-K… recallZ-2287-2025 · Spark Biomedical Inc · initiated Jul 2, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spark Biomedical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2287-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 2, 2025
- Posted by the FDA
- Aug 11, 2025
- Recalling firm
- Spark Biomedical Inc
- Quantity
- 78 units
- Product code
- PZR
- FDA submissions
- K230796
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial 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
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Sparrow Ascent Replacement Kit 11-110-KSpark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal1 recall0 reports
- Sparrow Ascent 28 Piece Kit (B2B) 11-320-K-28Spark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal1 recall0 reports
- Sparrow Ascent 28 Piece Kit (B2C) 11-310-K-28Spark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal1 recall0 reports
- Sparrow Ascent Kit (B2C) 11-310-KSpark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal1 recall0 reports
- Sparrow Ascent Kit (B2B) 11-320-KSpark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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