DiRex™ Steerable Sheath M004DS50S0Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729858997), received between Jun 23, 2020 and May 3, 2022 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PVC ABLATION PROCEDURE AND EXPERIENCED TWO DIFFERENT EVENTS. THE PATIENT EXPERIENCED A PERFORATION AND CARDIAC TAMPONADE. THE FIRST EVENT CAUSED A COMPLETE HEART BLOCK DURING A PVC ABLATION ON THE AORTIC CUSP. THE HEART BLOCK WAS CAUSED BY THE ABLATION OF LEFT SIDED PVC NEAR HIS. THE PATIENT RECEIVED A PACEMAKER AND WAS DISCHARGED. PT RECEIVED A TEMPORARY PACEMAKER AND WAS HELD OVER THE WEEKEND TO SEE IF CONDUCTION RETURNED. AN ORION CATHETER WAS USED TO MAP AND MIFI OI WAS USED DURING THE ABLATION AND THE SECOND EVENT CAUSED A PERFORATION OF THE LT ATRIUM DURING A TRANSEPTAL PUNCTURE. 1ST PUNCTURE WAS FINE AND USED ORION TO MAP LT ATRIUM. PHYSICIAN WAS UNABLE TO INSERT MEDTRONIC FREEZE SHEATH FOR CRYO ABLATION AND INSERTED A DIREX SHEATH INSTEAD. THE PHYSICIAN DIDN'T LIKE THE PLACEMENT OF THE FIRST PUNCTURE SO RE-INSERTED THE BRK NEEDLE THROUGH THE DIREX SHEATH AND PERFORATED THE LT ATRIUM. PATIENT HAD A TAMPONADE AND RECEIVED A PERICARDIOCENTESIS. PATIENT WAS STABLE AND WENT TO THE ICU. NO PATIENT OUTCOME: SERIOUS INJURY/ADVERSE PATIENT EFFECTS. DUE TO THE EVENTS AN ADDITIONAL SURGERY WAS PERFORMED. THERE WAS NO KNOWN DEVICE PROBLEM RE

  Patient problems: Cardiac Tamponade; Heart Block; Perforation of Vessels

  MAUDE report 14268643 ↗
• MalfunctionSep 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT WAS UNHARMED AND PROCEDURE WAS COMPLETED. THE FAULTY DEVICE WAS BACK. DURING THE DEVICE ANALYSIS IT WAS FOUND THE HEMOSTATIC VALVE WAS TORN AND LEAKING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421556 ↗
• MalfunctionJun 23, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE DIREX WAS REMOVED FROM THE PACKAGE AND WHEN BEING FLUSHED IT LEAKED FROM THE HANDLE WHERE THE TUBING ATTACHES. IT WAS USED FOR TREATMENT, HOWEVER SINCE THEY FOUND THE LEAK WHEN FLUSHING THE DIREX, IT WAS NEVER PUT INTO THE PATIENT. A NEW DIREX WAS PULLED AND USED WITH NO ISSUES. THE PATIENT WAS A MALE, APPROXIMATELY (B)(6), WEIGHT IS UNKNOWN. THE DIREX IS NOT BEING RETURNED FOR EVALUATION BECAUSE IT WAS LOST.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183952 ↗