DiRex™ Steerable Sheath M004DS40S0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729858973), received between Nov 8, 2023 and Apr 20, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 20, 2024Fluid/Blood Leak; Difficult to Advance; Fluid/Blood Leak; Difficult to Advance

  THE DIREX STEERABLE SHEATH WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT ATRIOVENTRICULAR NODAL RE-ENTRANT TACHYCARDIA. IT WAS REPORTED THAT THE SHEATH WAS FAULTY. THERE WAS A HEMOSTATIC VALVE LEAK AND THEY HAD DIFFICULTIES ADVANCING/WITHDRAWING THE CATHETER. IT WAS ALSO MENTIONED THAT MULTIPLE SHEATHS HAD DILATOR LUMEN OBSTRUCTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATION OCCURRED. THE EVENT DATE IS MARCH 21, 2024, AND THE LOT NUMBER IS PQOC17087.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149835 ↗
• MalfunctionNov 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER CONTACTED ME ABOUT A DEVICE MALFUNCTION. SHE SAID THE INNER LUMEN WAS MALFORMED AND WHEN FLUSHED FLUID CAME OUT OF THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18092171 ↗