Super Sheath (16035-06B) BT60Z11PGW038Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04543527181419), received between Oct 26, 2018 and Jul 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A WET FILM INSIDE THE STERILE PACKAGE WAS FOUND. A WET FILM WAS NOTED INSIDE THE STERILE PACKAGING OF A 6FX11CM SUPER SHEATH INTRODUCER SHEATH. THE OILY RESIDUE WAS SEEN INSIDE THE PACKAGE NEAR THE DEVICE HUB. WHEN THE PACKAGE WAS OPENED, IT WAS ALMOST OILY WHEN FELT. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314250 ↗
• MalfunctionMar 13, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A 6FX11CM AND 9FX11 CM SUPER SHEATH INTRODUCER SHEATHS WERE SELECTED FOR USE FOR A TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. DURING PREPARATION, A DISCOLORED LIQUID SUBSTANCE INSIDE THE PACKAGING OF THE DEVICE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SUPER SHEATH INTRODUCER SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9831054 ↗
• MalfunctionOct 26, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILE SEAL WAS DAMAGED. A 6F X 11CM .038 SUPER SHEATH WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT ONE OF THE PRODUCTS WAS NOT SEALED WHEN ONE OF THE BOXES WERE OPENED. ALSO, WHEN THEY WENT TO OPEN THE PRODUCT UP, THEY NOTICED THAT THE STERILE SEAL WAS NOT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8009891 ↗