ONE Snare® 00884450094891Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 16, 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 00884450094891), received between Dec 15, 2025 and Dec 15, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Perforation1
- Cardiac Tamponade1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RV LEAD DUE TO FRACTURE. THE LEAD WAS PREPPED WITH A SPECTRANETICS LLD TO PROVIDE TRACTION. BEGINNING WITH A SPECTRANETICS 13F TIGHTRAIL ROTATING DILATOR SHEATH, THE LEAD BROKE NEAR THE SVC COIL. THE TIGHTRAIL WAS REMOVED FROM THE BODY, AND THE DECISION WAS MADE TO SNARE FROM THE GROIN. A GORE MEDICAL 20F DRYSEAL FLEX INTRODUCER SHEATH WAS USED WITH AN ABBOTT AGILIS STEERABLE INTRODUCER. A MERIT MEDICAL ONE SNARE AND MERIT MEDICAL WHOLEY GUIDEWIRE WERE INITIALLY USED FOR SNARING. THE WHOLEY WIRE BROKE, SO THEN USED A BOSTON SCIENTIFIC SUPERSTIFF AMPLATZ GUIDEWIRE TO ATTEMPT TO GRAB THE LEAD. AFTER UNSUCCESSFUL ATTEMPTS TO PULL AND EXTRACT, SNARING CONTINUED WITH THE AMPLATZ WIRE AND MERIT MEDICAL ONE SNARE. THE LEAD WAS PULLED THROUGH THE SHEATH, THE ONE SNARE WAS DISENGAGED, AND WAS RAN OVER BOTH ENDS OF THE WIRE AT THE POINT OF THE LEAD. AFTER SUCCESSFULLY GRASPING THE LEAD, HE PULLED DOWN UNTIL THE LEAD DISLODGED FROM THE VASCULATURE. THE SVC COIL BROKE INTO TWO AND REMAINED IN THE SVC. THE REMAINING PORTION OF THE LEAD BROKE OFF AND STAYED INTACT AT THE DISTAL END. THEN, USING THE ONE SNARE, THE LOOSE END OF THE LEAD WAS PULLED
Patient problems: Cardiac Perforation; Cardiac Tamponade; Low Blood Pressure/ Hypotension
MAUDE report 23810469 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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