Super Sheath (16035-05B) BT50Z11PGW038Recalls & 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
- 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 04543527181402), received between Nov 24, 2020 and Nov 24, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 24, 2020Entrapment of Device; Entrapment of Device
IT WAS REPORTED THAT THE DEVICE LOCKED ON THE WIRE AND A DISSECTION OCCURRED. A 5F X 11CM SUPER SHEATH INTRODUCER SHEATH WITH 0.038IN MINI GUIDEWIRE WAS SELECTED FOR USE IN A PROCEDURE WITHIN THE FEMORAL ARTERY. THE POST-DILATED TARGET LESION WAS 300MM LONG WITH NO CALCIFICATION. DURING THE PROCEDURE, THE MINI GUIDEWIRE LOCKED ON TO THE NON-BOSTON SCIENTIFIC INTRODUCER NEEDLE. THE SUPER SHEATH INTRODUCER SHEATH WAS NEVER ADVANCED INSIDE THE BODY; ONLY THE MINI GUIDEWIRE THAT WAS PROVIDED WITH THE DEVICE WAS INSIDE THE BODY. THERE WAS BLEEDING FROM A SMALL RIFT IN THE VESSEL THAT REQUIRED EXTRA HAND COMPRESSION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Vascular Dissection
MAUDE report 10897154 ↗
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- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- 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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