ONO Retrieval Device ONO12-100Recalls & reported problems
Onocor LLC · Retrieval catheter with peel away sheath · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860008180605), received between May 9, 2025 and May 9, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Unfold or Unwrap” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Unfold or Unwrap2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
THE PEEL AWAY SHEATH WAS DIFFICULT TO PEEL, TAKES A LOT OF FORCE TO PEEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21999044 ↗MalfunctionMay 9, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
THE PEEL AWAY SHEATH WAS DIFFICULT TO PEEL, TAKES A LOT OF FORCE TO PEEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21999043 ↗
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.
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