DiRex Steerable SheathRecalls & reported problems across all models

We found 7 models of DiRex Steerable Sheath by Oscor Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2017 and Mar 26, 2025 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (15 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DiRex Steerable Sheath problems

DiRex Steerable Sheath models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DiRex™ Steerable Sheath M004DS200

  INTRODUCER, CATHETER
  5 reports
• DiRex™ Steerable Sheath M004DS300

  INTRODUCER, CATHETER
  5 reports
• DiRex™ Steerable Sheath M004DS500

  INTRODUCER, CATHETER
  5 reports
• DiRex™ Steerable Sheath M004DS50S0

  INTRODUCER, CATHETER
  3 reports
• DiRex™ Steerable Sheath M004DS40S0

  INTRODUCER, CATHETER
  2 reports
• DiRex™ Steerable Sheath M004DS100

  INTRODUCER, CATHETER
  1 report
• DiRex™ Steerable Sheath M004DS400

  INTRODUCER, CATHETER
  1 report

Recent DiRex Steerable Sheath adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 30, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED DURING RIGHT AFLUTTER ABLATION PROCEDURE THERE WAS BACK BLEEDING THROUGH HEMOSTASIS VALVE OF DIREX SHEATH. THE ISSUE WAS OBSERVED IMMEDIATELY AND WAS ADEQUATELY MANAGED. USING THE SAME SHEATH, THE PROCEDURE WAS SUCCESSFULLY ABLATED AND TERMINATED THE ARRHYTHMIA. THE SHEATH WAS DISPOSED OF AND NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11588135 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Oscor Inc. products

• Introducer Kit for Impella11 models · 1,326 reports · 9 recalls
• Guidestar Steerable Guiding Sheath2 models · 103 reports · 1 recall
• SafeSheath II14 models · 146 reports
• Destino Twist Steerable Guiding Sheath19 models · 45 reports · 1 recall
• SafeSheath Ultra Lite3 models · 24 reports · 1 recall
• Occlutech Delivery Set III10 models · 39 reports
• TourGuide Steerable Sheath9 models · 37 reports
• Lead Adaptor3 models · 20 reports