SafeSheath® Worley 00884450162286Recalls & reported problems
Merit Medical · Class 2
Data updated Oct 18, 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 00884450162286), received between Jan 6, 2022 and Jan 6, 2022 — classified as 1 injury.
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.
Most reported problems
Device problems
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2022Difficult to Remove; Difficult to Remove
THE ACCOUNT ALLEGES THAT DURING A CRTD PROCEDURE, WHILE ATTEMPTING TO REMOVE THE SHEATH, THEY WERE UNABLE TO REMOVE THE ENTIRE SHEATH DUE TO STRONG RESISTANCE. THE CLINICAN CUT THE SHEATH WITH A SCALPEL LEAVEING ONE PART OF THE SHEATH ON THE ELECTRODE AND THE OTHER REMAINED INSIDE THE PATIENT'S VEIN. THE PROCEDURE WAS REPORTED TO BE COMPLETED WITH NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13177577 ↗
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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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