Sparrow Ascent Patient Controller Recalled for Cable Disconnect
Spark Biomedical is recalling the Sparrow Ascent Patient Controller neurostimulator due to a manufacturing defect that causes cable disconnect errors and interrupts stimulation output. The recall affects 78 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall involving a manufacturing defect that causes loss of device function and interruption to therapeutic stimulation. While no injuries or hospitalizations have been reported, the recall addresses a risk-of-harm medical device where loss of critical therapeutic function could affect patient care, meeting the rubric criterion for High severity.
Plain-English summary
Spark Biomedical Inc is recalling the Sparrow Ascent Patient Controller, a neurostimulation device designed to deliver therapeutic electrical stimulation to patients. The recalled units carry REF numbers 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 is due to a manufacturing defect that causes the device to display a cable disconnect error message and interrupts the delivery of stimulation output. This manufacturing issue may prevent affected devices from functioning properly and delivering therapy to patients who depend on them.
The recall affects 78 units distributed nationwide in the United States. Affected devices carry lot numbers from V2408xxxx through V2519xxxx.
The recalled product
- 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
- Manufacturer
- Spark Biomedical Inc
- Category
- Medical Device — Neurostimulator
- Hazard
- cable-disconnect
- device-malfunction
- loss-of-function
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
Distributed nationwide across the United States.
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