ONE Snare® 00884450094822Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450094822), received between Nov 17, 2022 and Nov 17, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (1 report).
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2022Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
WHILE REVIEWING PMCF DATA IT WAS ALLEGED THAT A VASCULAR SNARE DEVICE WAS USED WITHIN THE CARDIOVASCULAR SYSTEM. THE DEVICE USE WAS OFF LABEL PER IFU. A PERFORATION WAS NOTED DURING A VASCULAR PROCEDURE. SURGICAL INTERVENTION AND CUT DOWN WAS REQUIRED TO REMOVE THE FOREIGN BODY FROM THE PATIENT. THE PHYSICIAN ALLEGES THAT THE EVENT HAS BEEN REPORTED TO THE MEDICAL MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15812079 ↗
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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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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