Sentrant™ SENSH1628W (UDI 00763000716257)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000716257), received between Mar 28, 2024 and Nov 11, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO SENTRANT SHEATHS WERE USED AS A CONDUIT DURING A TAVI PROCEDURE . IT WAS NOTED THAT THE PATIENT PRESENTED WITH BORDERLINE DIAMETERS AND SEVERE CALCIFICATION IN REGIONS OF THE RIGHT AND LEFT COMMON ILIAC ARTERIES, AND THE RIGHT AND LEFT COMMON FEMORAL ARTERIES. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TREATMENT OF THE COMMON ILIAC AND RIGHT COMMON FEMORAL ARTERIES WAS PERFORMED. SUBSEQUENTLY, THE 26 FX VALVE (LOT K128644) WAS MOUNTED ON THE DELIVERY SYSTEM (LOT 12526098), WITH SATISFACTORY FLUOROSCOPIC VERIFICATION. PRE-DILATION WAS PERFORMED WITH A 18 X 40 NON-MEDTRONIC BALLOON. DURING THE ATTEMPT TO INSERT THE DELIVERY SYSTEM THROUGH THE RIGHT COMMON FEMORAL ARTERY, IT WAS OBSERVED THAT, DUE TO SEVERE CALCIFICATION, THERE WAS NO PROGRESSION OF THE SYSTEM. SEQUENTIAL DILATION OF THE ARTERY WAS THEN PERFORMED WITH SENTRANT 12 FR, A 14 FR NON-MEDTRONIC DEVICE , AND SENTRANT 16 FR INTRODUCERS. HOWEVER, EVEN AFTER THE DILATIONS, THE DELIVERY SYSTEM DID NOT PROGRESS. SHORTLY AFTER, THE PATIENT PRESENTED WITH BLEEDING IN THE REGION OF THE RIGHT COMMON FEMORAL ARTERY AND HYPOTENSION, DUE TO VESSEL PERFORATION. ANGIOPLASTY WITH A 7X50 COVERED STENT WAS PERFORMED, FOLLOWED BY POS

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 23521903 ↗
• InjuryApr 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR AORTIC REPAIR INVOLVING A SENTRANT SHEATH, THE SIDE PORT FELL OFF, CAUSING BLEEDING FROM THE PORT. AFTER THE SHEATH WAS REMOVED, THE WIRE ACCESS WAS LOST, RESULTING IN A DELAY OF TREATMENT AND NECESSITATING MANUAL PRESSURE TO BE APPLIED TO THE SITE. THE PATIENT WAS ADMITTED TO THE CRITICAL CARE UNIT AND BROUGHT BACK TO THE CATHETER LAB 2 DAYS LATER TO FINISH THE EVAR PROCEDURE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 21771597 ↗
• MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A 16F SENTRANT SHEATH ((B)(6)) WAS INTENDED TO BE USED AS A CONDUIT DURING AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED DURING THE INDEX PROCEDURE, THE SHEATH WAS PLACED IN THE PATIENT AND UPON REMOVAL OF THE DILATOR, THE SENTRANT SHEATH MALFUNCTIONED, LEADING TO SIGNIFICANT BLOOD LOSS, THOUGH NO PATIENT INJURY OCCURRED. NO DAMAGE WAS OBSERVED ON THE SHEATH ITSELF, BUT SLIGHT DAMAGE AND BEND TO THE WAS NOTED. THE 16F SHEATH WAS REPLACED FOR A NEW SHEATH, WHICH SUCCESSFULLY CONTROLLED THE BLEEDING. THE IFU WAS FOLLOWED WHEN USING THE SENTRANT. PER THE PHYSICIAN THE CAUSE HEMOSTATIC VALVE LEAK WAS NOT DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20576347 ↗
• MalfunctionMar 28, 2024Material Deformation; Material Deformation

  A SENTRANT SHEATH WAS INTENDED TO BE USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED THAT DURING THE PREPARATION STAGE, IT WAS SEEN THAT THE TAPERED TIP OF THE SHEATH WAS BENT. THE ISSUE WAS NOTED AS THE DEVICE WAS TAKEN OUT OF THE BOX. THE SHEATH WAS THEREFORE NOT USED. A NEW SHEATH WAS OPENED. IT WAS CONFIRMED THE BOX AND PACKAGING WERE IN NORMAL CONDITION. PER THE PHYSICIAN THE CAUSE OF THE DEFORMATION WAS  A FAULTY SHEATH.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE DEVICE WAS NEVER USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995225 ↗