Single-Loop Snare Retrieval Kit 380911120Recalls & reported problems
Argon Medical Devices, Inc. · Single-Loop Snare Retrieval Kit · 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 00886333224609), received between Jan 18, 2022 and May 29, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Fragmentation1
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.
InjuryMay 29, 2025Break; Break
CUSTOMER REPORTED, "RADIOPAQUE TIP BROKE OFF OF THE INTERMEDIATE CATHETER FOR THE SNARE. TIP LODGE IN THE HEART AND WAS UNABLE TO BE RETRIEVED. NO IDENTIFIED CONTRIBUTING FACTORS. DR. DENIED ANY USE OUTSIDE OF NORMAL PRACTICES. SLIGHT CURVED SHAPE WAS ADDED TO THE CATHETER FOR DIRECTION ABILITY BUT THIS IS NOT OUTSIDE OF NORMAL PRACTICES. NO IDENTIFIED CHANGES IN PRACTICES. USER WAS PROPERLY TRAINED. NO NOTED PATIENT PATHOLOGIES OR CONDITIONS THAT WOULD CONTRIBUTE TO TIP BREAKING OFF. PATIENT IS STABLE BUT WILL REQUIRE ADDITIONAL MONITORING. PER DR., PATIENT WILL HAVE ADDITIONAL X-RAY TODAY, IN ONE WEEK, AND IN 3 MONTHS TO MONITOR FOREIGN OBJECT."
Patient problems: Foreign Body In Patient
MAUDE report 22107664 ↗MalfunctionJan 18, 2022Material Fragmentation
AFTER THEY SNARED THE FILTER WITH THE RETRIEVAL KIT SNARE, THE DOCTOR SINCHED THE FILTER INTO THE 9FR SHEATH. THE DOCTOR THEN SHEATHED DOWN OVER THE FILTER WITH THE 11FR SHEATH AND RETRIEVED THE FILTER. THEN THE DOCTOR PUSHED SOME CONTRAST IN THE 11FR SHEATH FOR A FINAL CAVAGRAM, AND IT LOOKED GOOD. THEN WHEN HE PULLED THE 11FR SHEATH OUT IT HAD A STRING OF THE INNER SHEATH ATTACHED TO THE END OF THE 11FR SHEATH. IT WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13280433 ↗
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.
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