Super Sheath (15-712B) BT60Z11PGW035 (UDI 04543527181587)Recalls & reported problems
Togo Medikit CO.,Ltd. · Class 2
All models of Super Sheath (14)
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 04543527181587), received between Apr 10, 2024 and Jun 27, 2024 — 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
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- 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.
InjuryJun 27, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SHEATH SEPARATED INSIDE THE BODY AND ADDITIONAL INTERVENTION WAS NEEDED TO REMOVE THE FRAGMENT. THIS SUPER SHEATH INTRODUCER SHEATH 6 FR X 11 CM .035 WAS SELECTED FOR PATENT FORAMEN OVALE (PFO) PROCEDURE WITH AN EXPERIENCED CARDIOLOGIST. PREPARATION OF THE SHEATH WAS FLUSHED/COMPLETED AND SHOWED NO ABNORMALITY. DURING THE PROCEDURE, UPON THE SECOND USE, THE OPERATOR HAD DIFFICULTY REMOVING THE SHEATH FROM THE VESSEL CAUSING THE SHEATH TO SEPARATE INSIDE THE PATIENT. ADDITIONAL INTERVENTION WAS PERFORMED TO OPEN THE VESSEL AND REMOVE THE BROKEN SHEATH FRAGMENT FROM THE PATIENT. DURING THE INTERVENTION, THE PATIENT LOST A LOT OF BLOOD. THE PATIENT HAD A PROLONGED HOSPITALIZATION; HOWEVER, WAS EXPECTED TO FULLY RECOVER. ANOTHER SUPER SHEATH WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19622758 ↗MalfunctionApr 10, 2024Break; Break
IT WAS REPORTED THAT THE SHEATH WAS BROKEN OR FRACTURED. A 6 FR X 11CM .035 SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SHEATH WAS BROKEN OR FRACTURED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19082996 ↗
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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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