Senovo Bi-Flex Steerable Guiding Sheath 454952Recalls & reported problems
Oscor Inc. · Steerable Guiding Sheath, 8.5F · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885672009915), received between Apr 20, 2023 and Feb 13, 2024 — classified as 2 injuries, 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Pericardial Effusion1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2024Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION, IT WAS REPORTED THIS EVENT WAS PART OF A STUDY, AND THE PATIENT LOSS APPROXIMATELY 50ML OF BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18699428 ↗InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT SUFFERED FROM A PERICARDIAL EFFUSION WITH LOW BLOOD PRESSURE, AND DIZZINESS AFTER TRANSSEPTAL PUNCTURE. THE PATIENT WAS HOSPITALIZED. FOR DIAGNOSTICS ECHOCARDIOGRAPHY WAS DONE. SUCCESSFUL PERICARIDAL PUNCTURE WITH 600 ML ASPIRATION WAS DONE. NO DEVICE MALFUNCTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pericardial Effusion
MAUDE report 17669830 ↗MalfunctionApr 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AT THE END OF THE SHEATH BLOOD CAME OUT OF THE VALVE. TILL THIS POINT THERE WAS NO NEEDLE OR CATHETER IN THE SHEATH. THE SHEATH WAS CHANGED TO A NEW SENOVO BI-FLEX STEERABLE GUIDING SHEATH. PATIENT WAS NOT SUBJECTED TO PROCEDURES WHICH MIGHT HAVE DAMAGED THE DEVICE. THE EVENT DID NOT CAUSE AN ADVERSE CHANGE IN THE PATIENT'S CONDITION. THE PATIENT IS 178CM (5'10") AND HAS A WEIGHT OF 84KG (186LBS). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16777174 ↗
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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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