Super Sheath (15-711B) BT50Z11PGW035Recalls & 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 04543527202435), received between Apr 8, 2020 and Apr 29, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
- Difficult to Remove1
Patient problems
- Hematoma1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2025Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT SHEATH WAS TORN CAUSING HEMATOMA. A 5 FR X 11 CM .035 INTRODUCER SHEATH WAS SELECTED FOR USE IN A RENAL EMBOLIZATION. DURING THE CLOSURE PROCESS OF THE PROCEDURE, A NON-BOSTON SCIENTIFIC VASCULAR CLOSURE WAS PLACED. UPON RETRACTING THE SHEATH, IT WAS NOTED THAT THE SHEATH TORE IN HALF CAUSING A HEMATOMA. MANUAL PRESSURE WAS APPLIED TO THE INCISION SITE. BOTH PARTS OF THE SHEATH WERE RECOVERED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.
Patient problems: Hematoma
MAUDE report 21927941 ↗MalfunctionApr 8, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A FOREIGN MATERIAL WAS PRESENT INSIDE THE DEVICE PACKAGING. A 5FRX11CM .035 SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING UNPACKING, WHEN THE DEVICE WAS OPENED, IT WAS NOTICED THAT A HAIR WAS INSIDE THE PACKAGING. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Patient Involvement
MAUDE report 9937997 ↗
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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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