ONE Snare® 00884450681725Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450681725), received between Jan 28, 2026 and Jan 28, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026Material Separation; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT WHILE USING A ONE SNARE DEVICE, THE DEVICE'S RADIOPAQUE MARKER DETACHED WHILE THE SNARE WAS IN THE PATIENT. THE DETACHED MARKER WAS UNABLE TO BE RETRIEVED AND ULTIMATELY BECAME EMBEDDED IN THE CORONARY SINUS OF THE PATIENT'S HEART. DUE TO THIS COMPLICATION, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 24199367 ↗
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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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