Sparrow Ascent 28 Piece Kit (B2C) 11-310-K-28Recalls & reported problems

Spark Biomedical Inc. · A starter pack with all the components for acute withdrawal management using Transcutaneous Auricular Neurostimulation (tAN®). This pack includes the Sparrow Ascent Kit and three Sparrow Ascent Left Earpiece Kits. (1) GTIN: 00860005396986 (Base kit containing the Patient Controller, Cable, Belt Clip, QSG, Batteries, seven Alcohol Wipes, and seven Left Earpieces) (3) GTIN: 00860005396993 · 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	`00850052017088`
Brand	Sparrow Ascent 28 Piece Kit (B2C)
Model	11-310-K-28
Company	Spark Biomedical Inc.
Product code	PZR · Percutaneous Nerve Stimulator For Opioid Withdrawal
Class	Class 2
FDA submission	K230796
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
Spark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal
1 recall0 reports
Sparrow Ascent Kit (B2C) 11-310-K
Spark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal
1 recall0 reports
Sparrow Ascent Kit (B2B) 11-320-K
Spark Biomedical Inc. · Percutaneous Nerve Stimulator For Opioid Withdrawal
1 recall0 reports
Sparrow Ascent 28 Piece Kit (B2B) 11-320-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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