GLIDESHEATH 40-1050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701011035), received between Jun 15, 2017 and Nov 23, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Kinked” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 23, 2020Material Frayed; Material Frayed

  ADDITIONAL INFORMATION WAS RECEIVED ON 30DEC2020. THE ARTERY WAS THE RADIAL ARTERY AND THERE WAS NO CALCIFICATION AND NO SPASM. THE REPORTED DEVICE WAS THE INITIAL PRODUCT THAT THEY USED AND THEN THEY SWITCHED IT OUT FOR A DIFFERENT GLIDESHEATH SLENDER SHEATH AND THEN IT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10885568 ↗
• MalfunctionJun 15, 2017Kinked; Kinked

  THIS REPORT IS BEING SUBMITTED IN RESPONSE TO (B)(4) WHICH WAS RECEIVED FROM THE FDA ON 5/17/17. THE EVENT DESCRIPTION STATES THE FOLLOWING: "BALANCE MIDDLE WEIGHT GUIDE WIRE WAS LOADED IN THE GLIDESHEATH. BMW WIRE BROKE INSIDE PATIENTS ARM. WHEN GLIDESHEATH WAS REMOVED, TIP OF GLIDESHEATH WAS BENT. CARDIOLOGIST MANAGED TO RETRIEVE THE BROKEN WIRE AND PATIENT NOT INJURED. IT WAS THE WIRE THAT BROKE, NO ISSUE WITH GLIDESHEATH."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6642953 ↗