Sparrow Ascent Kit (B2B) 11-320-KRecalls & reported problems

Spark Biomedical Inc. · The Sparrow Ascent 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 Sparrow Ascent 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. The Sparrow Ascent is to be used in clinical environments (e.g., doctor’s office, clinics, rehab centers, and hospitals) and/or at home. Users of the subject device include adults experiencing opioid withdrawal symptoms. Stimulation parameters (i.e., the strength of stimulation) are set by the user’s clinician, and users can only adjust stimulation intensity at home. The system consists of three main components 1) a disposable Earpiece, 2) a Cable, and 3) the External Pulse Generator (EPG). · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Jul 2, 2025Class IIOpen, Classified
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Z-2287-2025 · Root cause: Process control · Recall details · FDA record ↗

Device details

UDI-DI	`00860005396986`
Brand	Sparrow Ascent Kit (B2B)
Model	11-320-K
Company	Spark Biomedical Inc.
Product code	PZR · Percutaneous Nerve Stimulator For Opioid Withdrawal
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Oct 18, 2023

Device type (GMDN): Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator

A body-worn, electronic device intended to provide percutaneous electrical nerve field stimulation (PENFS) applied close to cranial/peripheral nerves around the external ear to achieve remote symptom relief mediated by central nervous system (CNS) pathways and structures [e.g., amygdala, spinal cord neurons]; depending on the treatment protocol and device settings it may be used for opioid withdrawal symptoms (e.g., bone/joint aches, tremor, anxiety), or irritable bowel syndrome [IBS]-associated functional abdominal pain (FAP). It consists of an electrical pulse generator with minimally-invasive electrodes, and accessories (e.g., adhesives, transilluminator). This is a single-use device.

Other Percutaneous Nerve Stimulator For Opioid Withdrawal devices

Sparrow Ascent Replacement Kit 11-110-K
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Sparrow Ascent Kit (B2C) 11-310-K
Spark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal
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Sparrow Ascent 28 Piece Kit (B2B) 11-320-K-28
Spark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal
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Sparrow Ascent 28 Piece Kit (B2C) 11-310-K-28
Spark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal
1 recall0 reports

All Percutaneous Nerve Stimulator For Opioid Withdrawal devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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