DiRex™ Steerable Sheath M004DS100Recalls & reported problems
Oscor Inc. · Steerable sheath, 8.5F · Class 2
All models of DiRex Steerable Sheath (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729858904), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood 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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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