Spark Biomedical recalls Sparrow Ascent Patient Controllers with specific model numbers due to potential cable disconnect errors that could interrupt stimulation. Affected units include REFs 11-110-K through 11-321-K-28 and specific lot numbers.
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Spark Biomedical is recalling certain Sparrow Ascent Patient Controllers because a manufacturing issue might cause the device to show a 'cable disconnect' error message and stop working properly. This could interrupt the patient's neurostimulation therapy, which is critical for medical treatment.
The device may display a 'cable disconnect' error message and stop delivering stimulation due to a manufacturing defect. This interruption could disrupt the patient's therapy, but the recall does not indicate immediate danger to life or serious injury.
Patients using the Sparrow Ascent Patient Controller for neurostimulation therapy are most at risk. The recall affects specific model numbers and lot ranges produced by Spark Biomedical.
Check for model references 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, or 11-321-K-28. The device was sold with lot numbers from V2408xxxx through V2519xxxx.
Identify your device's model reference from the list provided in the recall notice.
Reach out to Spark Biomedical for guidance on next steps if your device is affected.
The recall is due to a manufacturing issue that may cause the device to show a 'cable disconnect' error message and interrupt stimulation output.
Affected model references include 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, and 11-321-K-28.
The recall does not indicate a risk of serious injury; the hazard is limited to potential interruption of therapy.
We’ve drafted a message you can send Spark Biomedical to request your refund or repair — edit it as you like.
Subject: Recall Z-2287-2025 — Spark Biomedical Spark Biomedical Hello, I own a Spark Biomedical that is covered by recall Z-2287-2025 from Spark Biomedical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
