Sentrant™ SENSH1428W (UDI 00643169150317)Recalls & reported problems
Medtronic, Inc. · SHEATH SENSH1428W SENTRANT HYDRO · 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 00643169150317), received between Jun 5, 2018 and Jun 5, 2018 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Blood Loss1
- Injury1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2018Fluid/Blood Leak; Fluid/Blood Leak
A SENTRANT SHEATH WAS USED AS A CONDUIT DEVICE DURING THE ENDOVASCULAR TREATMENT OF A 51MM ABDOMINAL AORTIC ANEURYSM. A SHORT AND SEVERELY TORTUOUS ANEURYSMAL NECK WAS NOTED. MODERATE CALCIFICATION WAS OBSERVED IN BOTH ILIAC ARTERIES. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER A LIMB WAS CONTRALATERALLY INSERTED ON LEFT SIDE AND DEPLOYED, A 14 FR SENTRANT SHEATH WAS INSERTED AND ONCE THE DILATOR WAS REMOVED CONTINUOUS LEAKAGE WAS NOTED FROM THE HAEMOSTATIC VALVE. A 16 FR SENTRANT SHEATH WAS SUBSEQUENTLY INSERTED ON THE MAIN DEVICE SIDE WITH NO LEAKAGE REPORTED FROM THE HAEMOSTATIC VALVE. THE PHYSICIAN DECIDED TO COMPLETE THE PROCEDURE, REMOVE THE SHEATH, AND THEN STOP THE BLEEDING (CLOSE THE INCISION) RATHER THAN TO INSERT A NEW SHEATH BECAUSE THE EVENT OCCURRED AT THE END OF THE EVAR, HOWEVER PRIOR TO CLOSING THE INCISION, BLOOD PRESSURE DECLINED. THE DECREASE IN BLOOD PRESSURE WAS SUSPECTED TO BE DUE TO THE LEAKAGE FROM THE VALVE BECAUSE LEAKAGE FROM STENT GRAFT OR DAMAGE ON BLOOD VESSELS WAS NOT OBSERVED. BLOOD PRESSURE WAS CONTROLLED BY DRUGS ADMINISTERED BY ANAESTHESIOLOGY AND THE PATIENT RECOVERED. THE BLEEDING WAS STOPPED AND THE INCISION CLOSED. PER THE PHYSICIAN THE
Patient problems: Blood Loss; Injury; Low Blood Pressure/ Hypotension
MAUDE report 7568386 ↗
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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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