Super Sheath (15-707B) BT70Z07PGW035Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04543527197205), received between Apr 11, 2019 and Apr 11, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2019Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. A 7FRX7CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING PREPARATION, THE DEVICE WAS SELECTED KNOWING THAT THERE WAS NO RO MARKER ON THIS MODEL EVEN THOUGH THE ACCOUNT NORMALLY USES SHEATHS THAT HAVE RO MARKERS. DURING THE PROCEDURE INSIDE THE PATIENT, A COMPLETE CRACK/FRACTURE ALONG THE LENGTH OF THE DEVICE OCCURRED. IT WAS POSSIBLE THAT A BALLOON WAS INFLATED TOO SOON RELATING TO THIS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8503864 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- 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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