EN Snare® 00884450452455Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450452455), received between Feb 11, 2026 and May 26, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Physical Resistance/Sticking1
- Separation Problem1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Separation Problem
IT WAS REPORTED THAT THE TIP OF THE SNARE BROKE INSIDE A PATIENT'S BODY, DURING THE PROCESS OF GRASPING FOREIGN OBJECTS, WHICH PROLONGED THE PROCEDURE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25284889 ↗InjuryFeb 11, 2026Difficult to Remove; Physical Resistance/Sticking
CUSTOMER ALLEGED A LOT OF RESISTANCE GETTING THE SNARE BACK INTO THE CATHETER. THE DOCTOR AND HIS PA REPORTED THEIR RETRIEVAL CATHETER WAS COILING LIKE A RUBBER BAND UNDER THE TENSION. THE SNARE AND THE WIRE THAT WE WERE SNARING WERE PARTIALLY ATTACHED TO THE VESSEL. THE SURGICAL TEAM CAME IN TO WORK THOUGH THE CUT DOWN AND PATCH THE HOLE THAT WAS MADE WHILE TRYING TO GET THE SNARE AND WIRE OUT OF THE VESSEL. SHE SAID THAT IT WAS ALMOST COILED LIKE A PIGTAIL BUT NOT QUITE THAT TIGHT.
Patient problems: Foreign Body In Patient
MAUDE report 24312513 ↗
Other Device, percutaneous retrieval devices
- Gunther Tulip G13287Cook Incorporated · Device, percutaneous retrieval1 death98 reports
- CloverSnare G53008Cook Incorporated · Device, percutaneous retrieval32 reports
- Indy OTW G51836Cook Incorporated · Device, percutaneous retrieval17 reports
- Aveir™ LSCR111St. Jude Medical, Inc. · Device, percutaneous retrieval2 deaths15 reports
- Bard Snare OUS SRK35Heraeus Medical Components LLC · Device, Percutaneous Retrieval13 reports
- Indy OTW G51835Cook Incorporated · Device, percutaneous retrieval8 reports
- EN Snare® 00884450452462Merit Medical Systems, Inc. · Device, percutaneous retrieval7 reports
- Gunther Tulip G13287Cook Incorporated · Device, percutaneous retrieval6 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page