Sentrant™ SENSH2228W (UDI 00643169792623)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169792623), received between Mar 20, 2019 and Aug 15, 2023 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Use of Device Problem; Use of Device Problem

  A SENTRANT SHEATH WAS USED AS AN ACCESSORY DEVICE DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE DEVICE WAS USED 2 DAYS AFTER THE EXPIRATION DATE.   THERE WERE NO ISSUES NOTED TO THE DEVICE AND THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS. THE HEALTHCARE FACILITY ONLY NOTICED THE ISSUE AFTER USING THE DEVICE. IT WAS SAID THE SENTRANT WAS INITIALLY MEANT TO BE USED DURING A PROCEDURE WHICH WAS MEANT TO BE PERFORMED A MONTH PREVIOUSLY BUT ENDED UP BEING RESCHEDULED. AN ATTEMPT WAS MADE TO TRY TO COLLECT THE PRODUCT BEFORE ITS EXPIRATION DATE, AFTER THE DATE OF THE FIRST SURGERY THAT WAS NOT PERFORMED, HOWEVER, THE HOSPITAL REFUSED TO RETURN IT CLAIMING THAT IT WOULD HAVE A NEW DATE. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17547763 ↗
• InjurySep 2, 2021Difficult to Insert; Leak/Splash; Difficult to Insert; Leak/Splash

  A SENTRANT SHEATH WAS USED AS AN ACCESSORY DEVICE IN A PROCEDURE. IT WAS REPORTED DURING THE PROCEDURE, THAT THE SHEATH WAS INTRODUCED INTO THE PATIENTS LEFT FEMORAL ARTERY OVER A 0.35 NON MDT GUIDE WIRE. WHILE THE SHEATH WAS BEING INTRODUCED, THE PHYSICIAN  FELT THAT THERE WAS TOO MUCH LEAKING AROUND THE WIRE GOING THROUGH THE DILATOR. ONCE THE  SHEATH WAS INTRODUCED AND DILATOR WAS REMOVED, BLEEDING CEASED. THE PHYSICIAN FELT THAT THERE WAS TOO MUCH LEAKING IN THE DILATOR LUMEN AROUND 0.35 WIRE.THE PATIENT WAS HEPARINIZED AT THE TIME OF SHEATHS INTRODUCTION INTO BODY. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12412505 ↗
• DeathMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58 MM THORACIC AORTIC ANEURYSM. A SENTRANT SHEATH WAS ALSO USED DURING THE PROCEDURE TO ACCESS THE RIGHT ILIAC ARTERY. THE PATIENT'S EXTERNAL ILIAC ARTERIES WERE 7 MM IN DIAMETER. NO TORTUOSITY OR CALCIFICATION OF THE ACCESS VESSELS WAS NOTED. IT WAS REPORTED THAT THE NAVION DEVICE WAS PLACED THROUGH THE SENTRANT SHEATH AND ADVANCED INTO THE PATIENT'S DESCENDING THORACIC AORTA UNDER FLUOROSCOPY. THE STENT GRAFT WAS DEPLOYED SUCCESSFULLY, AND THE DELIVERY SYSTEM WAS RETRACTED AND REMOVED FROM THE PATIENT VIA THE SHEATH. THEREAFTER, THE SENTRANT SHEATH WAS REMOVED FROM THE PATIENT. WHEN IT WAS COMPLETELY REMOVED FROM THE PATIENT, THE PATIENT'S TISSUE WAS OBSERVED TO BE CONNECTED TO THE SHEATH AND IT WAS REPORTED THAT THE PATIENT'S RIGHT ILIAC ARTERY WAS AVULSED. FOLLOWING THAT OBSERVATION, THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DROPPED AND THEY EXPERIENCED UNCONTROLLED BLEEDING. THE PATIENT'S BLOOD PRESSURE WAS CONTROLLED BY REPAIRING THE ANATOMY, AND THEY WERE TRANSFERRED OUT OF THE OPERATING ROOM. THE PATIENT EXPIRED ONE DAY POST PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE A

  Patient problems: Blood Loss; Death; Perforation of Vessels

  MAUDE report 8435600 ↗