Super Sheath (15-720B) BT40Z11PPW035Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04543527181624), received between Apr 29, 2019 and Apr 29, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 18, 2026.
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE STERILE PACKAGE. FLUID WAS OBSERVED IN THE SUPER SHEATH INTRODUCER SHEATH STERILE PACKAGE NEAR THE END OF THE SHEATH. THE FLUID WAS VISIBLE WITHOUT OPENING THE PACKAGE. THE PACKAGING APPEARED NORMAL AND WAS INTACT. THERE WERE NUMEROUS SUPER SHEATH INTRODUCER SHEATH DEVICES OBSERVED TO HAVE THIS ISSUE. ONE OF THE PACKAGES WAS OPENED AND THE SUBSTANCE WAS NOTED TO BE OILY. THE DEVICES ARE ALL IN THEIR PACKAGES AND WERE NOT USED WITH A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8562385 ↗MalfunctionApr 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE STERILE PACKAGE. FLUID WAS OBSERVED IN THE SUPER SHEATH INTRODUCER SHEATH STERILE PACKAGE NEAR THE END OF THE SHEATH. THE FLUID WAS VISIBLE WITHOUT OPENING THE PACKAGE. THE PACKAGING APPEARED NORMAL AND WAS INTACT. THERE WERE NUMEROUS SUPER SHEATH INTRODUCER SHEATH DEVICES OBSERVED TO HAVE THIS ISSUE. ONE OF THE PACKAGES WAS OPENED AND THE SUBSTANCE WAS NOTED TO BE OILY. THE DEVICES ARE ALL IN THEIR PACKAGES AND WERE NOT USED WITH A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8562003 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 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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