Neurostimulator patient controllers recalled over cable disconnect errors interrupting stimulation output
Sparrow Ascent Patient Controllers are recalled because a manufacturing issue may produce a cable disconnect error message and interrupt stimulation output. 78 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes interruption of stimulation therapy and reports no injuries.
Plain-English summary
Sparrow Ascent Patient Controllers under 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 are being recalled. Affected lot numbers run from V2408xxxx through V2519xxxx. The recall covers 78 units distributed nationwide in the United States.
Because of a manufacturing issue, the neurostimulator device may display a cable disconnect error message and stimulation output may be interrupted. The FDA classified the action as Class II.
Patients and clinicians using an affected controller should follow the manufacturer's instructions for identifying affected units and arranging a replacement, and should contact their treating clinician about any interruption in therapy.
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
- Affected units
- 78
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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