Super Sheath R/O (15-965B) BT60Z25PPWX38Recalls & 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 04543527181860), received between May 31, 2023 and May 31, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Difficult to Remove1
- Material Deformation1
Patient problems
- 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.
MalfunctionMay 31, 2023Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 6 FR X 25 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE RIGHT ILIAC FROM A CONTRALATERAL APPROACH. HOWEVER, IT WAS NOTED THAT THE SHEATH WAS KINKED NEAR THE TIP OVER THE AORTIC BIFURCATION. CONSEQUENTLY, DIFFICULTY ADVANCING AND REMOVING THE SHEATH OCCURRED, AND THE PROCEDURE WAS DISCONTINUED. THE SHEATH WAS REMOVED INTACT FROM THE PATIENT'S BODY AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17030159 ↗
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
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- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
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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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