ONE Snare® 00884450094877Recalls & 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 00884450094877), received between Jul 27, 2022 and Jul 27, 2022 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Great Vessel Perforation1
- Myocardial Infarction1
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO PMCF DATA, AN ACCOUNT ALLEGES THAT WHILE RETRIEVING A STENT, FROM THE PERIPHERAL VASCULATURE, OF AN ADULT FEMALE, THE PATIENT EXPERIENCED - STROKE, MYOCARDIAL INFARCTION, AND VESSEL PERFORATION; HOWEVER, NO ADDITIONAL TREATMENT WERE REQUIRED. NO ADDITIONAL DETAILS AVAILABLE.
Patient problems: Great Vessel Perforation; Myocardial Infarction; Stroke/CVA
MAUDE report 15114710 ↗
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
- EN Snare® 00884450452479Merit Medical Systems, Inc. · 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 16, 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