DiRex™ Steerable Sheath M004DS200Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729858928), received between Sep 3, 2021 and Mar 26, 2025 — 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.

• MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE SHEATH WAS BACK BLEEDING UPON INSERTION. PATIENT PRESENT AT TIME OF EVENT. PROCEDURE COMPLETED USING DIFFERENT DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21700133 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING PROCEDURE DIREX SHEATH WAS LEAKING OUT OF THE FLUSH TUBING AT THE SITE OF HANDLE. THERE WAS NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491772 ↗
• MalfunctionJan 27, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED, LAB STAFF NOTIFIED EP REP THAT DIREX STEERABLE SHEATH HEMOSTASIS VALUE WAS LEAKING DURING PROCEDURE. PHYSICIAN REPLACED SHEATH WITH ANOTHER DIREX WHICH RESOLVED THE ISSUE. THE LOT NUMBER IS UNKNOWN AND THE DEVICE WAS DISPOSED OF ON SITE. NO PATIENT HEALTH CONSEQUENCES OR IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366030 ↗
• MalfunctionDec 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE END OF THE SHEATH WAS LEAKING DURING AN ABLATION PROCEDURE, THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13001280 ↗
• MalfunctionSep 3, 2021Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT A DIREX STEERABLE SHEATH WAS USED IN A PROCEDURE. HOWEVER IT WAS NOTED THAT DURING THE PROCEDURE A UNSPECIFIED SHEATH COMPLICATION OCCURRED DURING THE PROCEDURE. IT WAS FURTHER REPORTED ON 21JUN2021 THAT DURING THE CASE A SHEATH COMPLICATION OCCURRED WHILE THE PATIENT WAS ON THE TABLE; TWO OF THE SHEATHS PORTS WERE NOT ABLE TO FLUSH. THE THIRD SHEATH WAS USED. NO KNOWN PATIENT COMPLICATIONS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421798 ↗