Home › Spark Biomedical Inc. › Sparrow Ascent Replacement Kit
Sparrow Ascent Replacement Kit
Spark Biomedical Inc. · Model 11-110-K · UDI-DI 00850052017033
PZR
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
6
Facilities
Description
Separate item for replacement. The Sparrow Ascent Patient Controller is a transcutaneous auricular neurostimulation (tAN) system intended to provide non-invasive, transcutaneous stimulation of the nerves on and/or around the auricle (ear). The device is indicated as an aid in the reduction of opioid withdrawal symptoms in adult patients. The Patient Controller is a battery operated, prescription device that delivers mild electrical stimulation to the nerves on and/or around the auricle (ear), which carry information to the central nervous system.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-02 | Spark Biomedical Inc | Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.