Super Sheath XL (15-737B) CI12L25TP0038Recalls & reported problems
Togo Medikit CO.,Ltd. · 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 04543527202015), received between May 20, 2024 and May 20, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Low Blood Pressure/ Hypotension1
- Sepsis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPOTENSION AND BECAME SEPTIC REQUIRING ADMITTANCE TO INTENSIVE CARE UNIT AND PROLONGED HOSPITALIZATION. A 12 FR X 25 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE IN A NON-STENOSED VESSEL FOR A PERCUTANEOUS CHOLANGIOSCOPY PROCEDURE. DURING THE PROCEDURE, WHILE IRRIGATING THE BILIARY SYSTEM WITH SALINE, THE INTRODUCER SHEATH DID NOT ALLOW FOR ADEQUATE PRESSURE TO BE RELEASED. AS A RESULT, THE PATIENT BECAME HYPOTENSIVE AND SEPTIC AFTER THE PROCEDURE, REQUIRING ADMITTANCE TO THE INTENSIVE CARE UNIT (ICU). THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PATIENT HAS RECOVERED AND HAS BEEN DISCHARGED.
Patient problems: Low Blood Pressure/ Hypotension; Sepsis
MAUDE report 19350303 ↗
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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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