DuraSheath Introducer Sheath System 6F, 45cm, straigthRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04251244500160), received between Feb 6, 2020 and Feb 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionFeb 6, 2020Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  THE FOLLOWING DESCRIPTION OF THE INCIDENT WAS REPORTED THROUGH THE COMPLAINT NOTIFICATION FORM: "DURING THROMBOSUCTION PROCEDURE SHEATH BLOCKED AND THEY COULD NOT RETRIEVE IT. THEN IT BROKE DURING FIRM RETRIEVING AND THE BRAIDING CAME ALL OVER THE 0.035 WIRE AS SPIRAL. ONE PART WAS LEFT BEHIND IN THE PATIENT AND WENT TO THE OR." THE PATIENT HAD TO WENT TO THE OPERATIONAL ROOM WHERE OPERATOR CUT DOWN OF THE GROIN. IN THE PROCEDURE WAS INVOLVED OTHER MEDICAL DEVICE: JETI THROMBOSUCTION DEVICE. ADDITIONAL INFORMATION RECEIVED BY THE DISTRIBUTOR ON 17.01.2020: "THE VASCULAR SURGEON MADE A SMALL CUT IN THE GROIN AND THEN THE REST OF THE SHEATH CAME OUT VERY EASY. PATIENT IS DOING WELL. THE SUCTION CATHETER WAS STOCKED IN DURASHEATH AND EVERYTHING HAS TO COME OUT IN THE HOPE TO PLACE A 7FR. DURASHEATH INSTEAD."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9675210 ↗