GLIDESHEATH SLENDER 50-1070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00389701011370), received between Oct 28, 2019 and Jul 20, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 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.

• MalfunctionJul 20, 2021Break; Break

  THE USER FACILITY REPORTED THAT THE WIRE INCLUDED WITH THE GLIDESHEATH SLENDER SHEATH UNRAVELED. ADDITIONAL INFORMATION WAS RECEIVED ON 09JUL2021. THE USER FACILITY STATED THAT THE WIRE LOOKED FINE GOING INTO THE NEEDLE WHILE SITTING IN THE RADIAL ARTERY, HOWEVER THE DOCTOR COULD NOT INSERT IT, SO THEY REPOSITIONED THE NEEDLE. AS THE DOCTOR CAME OUT WITH THE WIRE TO REINSERT, HE NOTICED THAT IT HAD UNRAVELED. A NEW WIRE WAS USED FOR THE SAME SHEATH AS THE PROBLEM WAS WITH THE WIRE. THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199322 ↗
• InjuryOct 28, 2019Break; Difficult to Insert; Physical Resistance/Sticking; Break; Difficult to Insert; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE A GLIDESHEATH SLENDER WIRE BROKE OFF IN NEEDLE. IT WAS REPORTED THAT THE PATIENT IS RECOVERING AND FINE. THE PATIENT HAD A CENTRAL LINE PLACED IN THE R SUBCLAVIAN ARTERY. THE DOCTOR DID R RADIAL ACCESS AND PLACED A VIABAHN WHILE SOMEONE PULLED THE LINE AND IT WENT WELL WITH ONE EXCEPTION. THE RESIDENT DID THE ACCESS, GOT IN AND ATTEMPTED TO THREAD THE WIRE BUT IT WOULD NOT GO. THEY WENT TO PULL THE WIRE BACK AND IT BECAME STUCK IN THE NEEDLE WHICH SHEARED THE TIP OF THE WIRE OFF. SO, THEY HAD TO DO A CUT DOWN AND GET IT OUT. THE DOCTOR TYPICALLY FEELS THE STUCK RESISTANCE AND JUST USUALLY PULLS OUT THE WIRE AND THE NEEDLE SO CASES LIKE THIS DOES NOT HAPPEN. THE ESTIMATED BLOOD LOSS WAS LESS THEN 250CC'S. A CUT DOWN WAS PERFORMED TO REMOVE THE PIECE OF WIRE. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED 03OCTOBER2019: THE PROCEDURE PERFORMED WAS A RIGHT EXCLUDING STENTING.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9244045 ↗