Super Sheath R/O (15-962B) BT60Z11PPWX38Recalls & 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
Quick summary
This is a Boston Scientific Super Sheath R/O introducer sheath, a catheter sleeve used to guide wires and devices into blood vessels during procedures like angioplasty. The 49 reports mostly describe contamination or residue found in or on the sheath, including fluid inside unopened sterile packaging, plus a few cases where the sheath was hard to advance or remove and its tip deformed and caught on the vessel wall. No deaths and no injuries were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 04543527181808), received between Apr 29, 2019 and Dec 5, 2023 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (46 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.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material46
- Device Contaminated During Manufacture or Shipping2
- Difficult to Advance1
- Difficult to Remove1
- Material Integrity Problem1
Patient problems
- No Patient Involvement26
- No Consequences Or Impact To Patient22
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2023Difficult to Remove; Difficult to Advance; Material Integrity Problem; Difficult to Remove; Difficult to Advance; Material Integrity Problem
IT WAS REPORTED THAT THE SHEATH WAS DIFFICULT TO REMOVE. A 6FR INTRODUCER SHEATH WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE TO TREAT AN OCCLUDED VESSEL. DURING INSERTION OF THE SHEATH, THERE WAS DIFFICULTY ADVANCING THE SHEATH. WHEN THE SHEATH WAS REMOVED, THE TIP WAS DEFORMED. IT WAS DIFFICULT TO REMOVE, AND THE TIP CAUGHT ON THE VESSEL WALL. A NEW SHEATH WAS SELECTED FOR USE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18270360 ↗MalfunctionMay 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10038548 ↗MalfunctionMay 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10038514 ↗MalfunctionMay 8, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10038513 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10036750 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10036677 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035773 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035722 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035693 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035671 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035668 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10035642 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10033359 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10033317 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10033301 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10033297 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10033233 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10032659 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10032289 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10032287 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10032285 ↗MalfunctionMay 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10032284 ↗MalfunctionMay 6, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
BOSTON SCIENTIFIC RECEIVED AN UNUSED AND UNOPENED PACKAGE WITH NO REPORTED ALLEGATION FROM THE HEALTHCARE FACILITY. UPON INITIAL OBSERVATION, IT WAS OBSERVED THAT THERE WAS FLUID AT THE HUB OF THE DEVICE INSIDE THE STERILE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 10030913 ↗MalfunctionApr 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. A 6 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. CONDENSATION WAS NOTED INSIDE THE INTERNAL PACKAGING AT THE HUB OF THE SHEATH. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 9963841 ↗MalfunctionApr 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS CONDENSATION IN THE PACKAGING. THE 6 FR X 11 CM SUPER SHEATH INTRODUCER SHEATH WAS SELECTED FOR USE. CONDENSATION WAS NOTED INSIDE THE INTERNAL PACKAGING AT THE HUB OF THE SHEATH. NO PATIENT WAS INVOLVED AT THE TIME OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9963796 ↗
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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