DiRex™ Steerable Sheath M004DS300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729858942), received between Nov 11, 2019 and Sep 13, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DIREX STEERABLE GUIDING SHEATH WAS LEAKING THROUGH VALVE. THERE WAS NO KNOWN ADVERSE PATIENT SIDE EFFECTS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463855 ↗
• MalfunctionDec 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A BUBBLE LEAKAGE FROM INSIDE THE INTRODUCER FROM THE INFERIOR VALVE. THE ISSUE OCCURRED DURING AN ATRIAL FIBRILLATION PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934440 ↗
• MalfunctionOct 26, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING PROCEDURE HEMOSTATIC VALVE OF STEERABLE GUIDING SHEATH WAS LEAKING. THERE WAS NO KNOWN PATIENT SIDE EFFECTS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10734645 ↗
• MalfunctionApr 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT DURING A PROCEDURE THERE WAS BLOOD LEAKING FROM THE CATHETER HANDLE. THE SHEATH WAS IRRIGATED WITH AN UNDER PRESSURE SALINE BAG. DUE TO THE LEAK AND BLOOD LOSS THE SHEATH HAD TO BE CHANGED. THE AMOUNT OF BLOOD LOSS IS UNKNOWN. NO SURGERY OR BLOOD PRODUCT NEEDED TO CONTROL THE BLOOD LOSS. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9918097 ↗
• MalfunctionNov 11, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT: AT THE UNIKLINIK REGENSBURG WE HAD TWO DIREX SHEATHS WITH MALFUNCTIONS. THE HEMOSTATIC SEAL OF THE FIRST SHEATH WAS BROKEN AND THEREFORE THE DILATOR COULD NOT BE ADVANCED INTO THE SHEATH AND WAS THEREFORE EXCHANGED. THE SECOND SHEATH HAD A BROKEN STEERING AND ONLY ONE SIDE OF THE CURVE WAS OPERABLE THIS RESULTED IN ANOTHER SHEATH EXCHANGE. THE THIRD ONE WORKED WITHOUT ANY FURTHER ISSUES AND THE CASE WAS COMPLETED. BOTH SHEATHS ARE FROM THE SAME LOT. IT WAS REPORTED NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING THE EVENT DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9306792 ↗