DiRex™ Steerable Sheath M004DS400Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729858966), received between Mar 15, 2017 and Mar 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air Leak” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2017Air Leak; Air Leak

  PER SHORT FORM: DR HAD AN ISSUE WITH A SHEATH RECENTLY DURING A PVI IN THAT THE VALVE WAS LEAKING AND ALLOWING AIR IN THE SYSTEM'. PER SHORT FORM: PROCEDURE OUTCOME: A DIFFERENT SHEATH. DEVICE USED FOR TREATMENT OR DIAGNOSIS? NO. WHEN WAS THE PROBLEM NOTICED: DURING PROCEDURE WHERE DID PROBLEM OCCUR: INSIDE THE PATIENT. FIRST TIME UNIT WAS USED: YES. TREATMENT OR DIAGNOSIS: TREATMENT. SEE BELOW REGARDING SR RESPONSE. WHAT WAS THE PATIENT'S AGE, GENDER AND WEIGHT? (B)(6). WHERE THERE ANY PATIENT COMPLICATION'S DUE TO THE EVENT? NO COMPLICATIONS AS ISSUE WAS DETECTED, HOWEVER CHANGE OF SHEATH WAS REQUIRED. CAN YOU PLEASE CLARIFY THE STATEMENT "ALLOWING AIR IN THE SYSTEM"? THE ONE WAY VALVE WAS NOT FUNCTIONING CORRECTLY AND ALLOWING BLOOD OUT OF THE SYSTEM, AS WELL AS LETTING AIR INTO IT. WAS THE AIR IN THE SYSTEM DETRIMENTAL TO THE PATIENTS' HEALTH STATUS? IF CONTINUED USE OF THE SHEATH HAD BEEN ALLOWED THEN YES AS IT COULD OF INTRODUCED AIR EMBOLI INTO THE LEFT SIDE OF THE PATIENTS HEART RESULTING IN STROKE OR MI.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6408059 ↗