Super Sheath (15-721B) BT50Z11PPW038Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04543527181631), received between Apr 6, 2020 and Apr 6, 2020 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 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 Contamination with Chemical or Other Material6
Patient problems
- No Consequences Or Impact To Patient6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS MOISTURE IN THE PACKAGING. THE 5 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING PREPARATION, MOISTURE WAS NOTED IN THE INTERNAL PACKAGING AND THERE WAS CONCERN REGARDING THE STERILITY OF THE SHEATH. A NEW SUPER SHEATH INTRODUCER SHEATH WITH A DIFFERENT BATCH NUMBER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929290 ↗MalfunctionApr 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS MOISTURE IN THE PACKAGING. THE 5 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING PREPARATION, MOISTURE WAS NOTED IN THE INTERNAL PACKAGING AND THERE WAS CONCERN REGARDING THE STERILITY OF THE SHEATH. A NEW SUPER SHEATH INTRODUCER SHEATH WITH A DIFFERENT BATCH NUMBER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929154 ↗MalfunctionApr 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS MOISTURE IN THE PACKAGING. THE 5 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING PREPARATION, MOISTURE WAS NOTED IN THE INTERNAL PACKAGING AND THERE WAS CONCERN REGARDING THE STERILITY OF THE SHEATH. A NEW SUPER SHEATH INTRODUCER SHEATH WITH A DIFFERENT BATCH NUMBER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929134 ↗MalfunctionApr 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS MOISTURE IN THE PACKAGING. THE 5 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING PREPARATION, MOISTURE WAS NOTED IN THE INTERNAL PACKAGING AND THERE WAS CONCERN REGARDING THE STERILITY OF THE SHEATH. A NEW SUPER SHEATH INTRODUCER SHEATH WITH A DIFFERENT BATCH NUMBER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929127 ↗MalfunctionApr 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS MOISTURE IN THE PACKAGING. THE 5 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING PREPARATION, MOISTURE WAS NOTED IN THE INTERNAL PACKAGING AND THERE WAS CONCERN REGARDING THE STERILITY OF THE SHEATH. A NEW SUPER SHEATH INTRODUCER SHEATH WITH A DIFFERENT BATCH NUMBER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9929125 ↗MalfunctionApr 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS MOISTURE IN THE PACKAGING. THE 5 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING PREPARATION, MOISTURE WAS NOTED IN THE INTERNAL PACKAGING AND THERE WAS CONCERN REGARDING THE STERILITY OF THE SHEATH. A NEW SUPER SHEATH INTRODUCER SHEATH WITH A DIFFERENT BATCH NUMBER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9928936 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
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- 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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