DiRex™ Steerable Sheath M004DS500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729858980), received between Nov 6, 2017 and Oct 29, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2019Break; Fluid/Blood Leak; Material Fragmentation; Break; Fluid/Blood Leak; Material Fragmentation

  CATHETER SHAFT PEELING/FLAKING/SHEARING WAS OBSERVED. WHILE INSERTING DILATOR INTO SHEATH CUSTOMER FELT NORMAL RESISTANCE. THE VALVE BEGAN INSTANTLY LEAKING BLOOD. PHYSICIAN PLUGGED VALVE CLOSED WITH FINGER AND INTRODUCED THE WIRE AGAIN. AMOUNT OF BLOOD LOSS WAS NOMINAL. VALVE LOOKED NORMAL BUT SEAL OBVIOUSLY COMPROMISED. DIFFERENT SHEATH WAS USED WITH WIRE. THERE WAS SURGICAL DELAY REPORTED. NO PATIENT SIDE EFFECT OR SERIOUS INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9252417 ↗
• MalfunctionOct 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING TRANSEPTAL ACCESS SHEATH'S HEMOSTASIS VALVE WAS COMPROMISED. BACKFLOWS WAS SIGNIFICANT ENOUGH FOR THEM TO EXCHANGE SHEATH OF A SIMILAR MODE. SHEATH WAS REMOVED AND PROCEDURE COMPLETED WITH SIMILAR MODEL DIFFERENT DEVICE. THERE WAS NO PATIENT SIDE EFFECT OR ADVERSE EVENT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226860 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT PROXIMAL END OF DILATOR BROKE OFF DURING TRANSSEPTAL INSIDE THE PATIENT BODY. THE HUB BROKE OFF AFTER TRANSSEPTAL CROSSING WHEN ATTEMPTING TO REMOVE THE DILATOR AND WIRE FROM THE SHEATH. DILATOR WAS REMOVED WHEN THE PHYSICIAN PLACED A CLAMP ON IT. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO SURGICAL DELAY REPORTED. THERE WAS NO ADVERSE EFFECTS TO THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8089927 ↗
• InjuryNov 6, 2017Difficult to Advance; Difficult to Advance

  THEY THOUGHT THAT THE DILATOR WAS WAY TOO TIGHT AND THEY DIDN'T USE AT ALL BUT THEY OPENED IT. THE EVENT HAPPENED DURING THE PROCEDURE OUTSIDE THE PATIENT'S BODY. UNFORTUNATELY, THEY ABANDONED THE CASE AND THEY HAD TO DO CARDIAC TAMPONADE TO MAKE SURE TO GET THE FLUID OR THE BLOOD OUTSIDE THE PERICARDIUM. NO COMPLICATIONS. PATIENT IS STABLE AND FINE.

  Patient problems: Cardiac Tamponade

  MAUDE report 7004698 ↗
• InjuryNov 6, 2017Break; Break

  THE DILATOR IN THE SHEATH BROKE OFF SO THE END OF THE DILATOR CRACKED AND THAT CAUSED THE SHEATH TO PROPEL FORWARD AND IT PUNCTURED THE HEART. THE EVENT HAPPENED DURING THE PROCEDURE INSIDE THE PATIENT'S BODY.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 7004527 ↗