Sentrant™ SENSH2028W (UDI 00763000716271)Recalls & reported problems
Medtronic, Inc. · SENTRANT INTRODUCER SHEATH 20 FR X 28 CM · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000716271), received between Oct 29, 2024 and Oct 29, 2024 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF 1 61MM AAA . A 20FR SENTRANT SHEATH WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE 2 VALIANT CAPTIVIA STENT GRAFTS WERE DELIVERED DIRECTLY WITHOUT THE USE OF A INTRODUCER SHEATH. A SENTRANT SHEATH WAS USED TO BACK-FILL. POST BALLOONING AND DURING THE FINAL RUN, THE SENTRANT SHEATH WITHDREW FROM THE AORTA. PRIOR TO THE PHYSICIAN GAINING CONTROL THE PATIENT LOST APPROX. 1000CC OF BLOOD BEFORE THE PHYSICIAN REGAINED HEMOSTATIC CONTROL. THE PHYSICIAN CLOSED THE AORTA AND 3 UNITS OF BLOOD WERE GIVEN TO THE PATIENT. THE PATIENT WAS FOLLOWING COMMANDS, MOVING BOTH FEET, AND HAD DOPPLER SIGNALS, AND GOOD URINE OUTPUT POST PROCEDURE. IT WAS CONFIRMED THE VALIANT STENT GRAFTS DID NOT CAUSE OR CONTRIBUTE TO THE BLOOD LOSS AND THERE IS NO ALLEGATION AGAINST THEM. THE SENTRANT SHEATH DID LEAD TO THE BLOOD LOSS DUE TO BEING WITHDRAWN PREMATURELY, IT WAS WITHDRAWN PREMATURELY DUE TO THE AREA BEING CONFINED AND AN INABILITY TO VISUALIZE THE SHEATH. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20555133 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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