Super Sheath R/O (15-958B) BT70Z07PPWX38Recalls & reported problems
Togo Medikit CO.,Ltd. · Class 2
All models of Super Sheath R/O (9)
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 04543527181754), received between Sep 7, 2021 and Sep 7, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 7, 2021Break; Break
IT WAS REPORTED THAT THE RADIOPLAQUE TIP BROKE OFF. THE 80% STENOSED TARGET LESION WAS LOCATED IN A FISTULA VENOUS ANASTOMOSIS OF THE LEFT ARM. A SUPER INTRODUCER SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RADIOPLAQUE TIP BROKE OFF WHEN PULLING THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT WAS NOT INTACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 12434277 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 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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