Super Sheath (16034-04B) BT40Z11PGW035Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04543527181396), received between Jul 21, 2020 and Jul 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 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 4FX11CM 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 10304627 ↗