EN Snare® 00884450452424Recalls & 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 00884450452424), received between Apr 25, 2023 and Oct 18, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 reports).
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
- Fracture2
- Material Integrity Problem1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2023Fracture; Fracture
CUSTOMER ALLEGES THE TIP OF THE SNARE BROKE OFF AND THEY USED ANOTHER SNARE TO REMOVE THE TIP. NO PATIENT INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 17958413 ↗MalfunctionApr 25, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A BALLOON DILATION PROCEDURE WITHIN THE PULMONARY ARTERY THROUGH THE FEMORAL VEIN OF A 1-YEAR-OLD PATIENT, THE TIP OF THE GUIDEWIRE DETACHED WHILE THE WIRE WAS WITHDRAWN. A SNARE WAS USED TO REMOVED THE TIP OF THE WIRE, AFTER GRIPPING THE TIP, RESISTANCE WAS FELT AND PART OF THE SNARE WIRE DETACHED AND REMAINED WITHIN THE VESSEL. THE PROCEDURE WAS COMPLETED WITH THE TIP OF THE WIRE AND FRAGMENT OF THE SNARE LEFT WITHIN THE PATIENT IN THE PERIPHERAL REGION OF THE LUNG. PHYSICIAN DOES NOT CONSIDER REMAINING FRAGMENTS TO BE LIFE-THREATENING.
Patient problems: Foreign Body In Patient
MAUDE report 16811542 ↗
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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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