Sentrant™ SENSH1428W (UDI 00763000716240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000716240), received between Jan 6, 2025 and Jun 12, 2026 — classified as 2 deaths, 1 injury, 1 malfunction.

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.

• MalfunctionJun 12, 2026Material Deformation

  A SENTRANT SHEATH WAS USED AS A CONDUIT DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED DURING THE INDEX PROCEDURE, WHEN THE SENTRANT SHEATH WAS INTRODUCED INTO THE PATIENT'S FEMORAL INLINE, THERE WAS A FAILURE AT THE TIP OF THE SENTRANT WHICH MADE DEVICE NAVIGATION IMPOSSIBLE. A REPLACEMENT SENTRANT FROM THE SAME BATCH THAT HAD NO DEFECTS WAS USED AND THE TREATMENT PROCEEDED AS EXPECTED. THE CAUSE WAS NOT REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482777 ↗
• InjuryJun 26, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TRANSCATHETER AORTIC VALVE REPLACEMENT, THE SHEATH SENSH1428W SENTRANT HYDRO EXPERIENCED A SHEATH VALVE DETACHMENT WHEN THE VALVE CAME OFF WITH THE DILATOR, RESULTING IN BACKFLOW OF BLOOD. THE DEVICE WAS REPLACED WITH A NEW SHEATH. THE SENTRANT WAS USED AS PER INSTRUCTIONS FOR USE (IFU) AND APPEARED NORMAL PRIOR TO USE. THE PATIENT EXPERIENCED A BLOOD LOSS OF 750 ML AND RECEIVED A TRANSFUSION OF ONE UNIT OF BLOOD DUE TO THE BLOOD LOSS ASSOCIATED WITH THE SENTRANT SHEATH PER THE PHYSICIAN THE CAUSE OF THE DETACHMENT COULD NOT BE DETERMINED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22335397 ↗
• DeathMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH WAS USED IN A TAVI PROCEDURE BEFORE THE PRE-DILATION OF THE AORTIC VALVE. IT WAS NOTED THAT DUE TO SEVERE CALCIFICATION OF THE FEMORAL ILIAC PATHWAY, THE ARTERIES HAD A SMALLER DIAMETER THAN RECOMMENDED. IT WAS STATED THE VASCULAR SPECIALIST WAS AWARE OF THIS BUT STILL DECIDED TO ATTEMPT THE PROCEDURE VIA THE RIGHT FEMORAL ARTERY. DURING THE PROCEDURE, AFTER PREPARING THE PRO PLUS 23 LOT: J304417 IN D-EVPROP23-29, THE 14F SENTRANT WAS INTRODUCED INTO THE RIGHT FEMORAL ARTERY WITH DIFFICULTY. THE VASCULAR TEAM PERFORMED ANGIOPLASTY IN THE COMMON ILIAC AND RIGHT EXTERNAL ILIAC WITH A 7X40 BALLOON, PRE-DILATED THE AORTIC VALVE WITH A NON-MDT 18X40 BALLOON. THE 14F SENTRANT WAS REMOVED AND THE VASCULAR TEAM WAS UNABLE TO PROGRESS WITH THE VALVE DELIVERY SYSTEM THROUGH THE RIGHT FEMORAL ARTERY, SO A NEW ANGIOPLASTY WAS PERFORMED WITH A 7X120 BALLOON IN THE COMMON AND EXTERNAL ILIAC ARTERY AND COMMON FEMORAL ARTERY. AFTER IMAGE CONTROL, THE DOCTORS SHOWED BLOOD EXTRAVASATION IN THE EXTERNAL ILIAC AND FEMORAL ARTERY AND SEVERE HYPOTENSION. A 7X58 COVERED STENT WAS IMPLANTED IN THE EXTERNAL ILIAC, AND OPEN BYPASS SURGERY WITH GRAFT WAS CHOSEN. THE PATIENT WAS TREATED WITH

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 22060802 ↗
• DeathJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SENTRANT SHEATH (SENSH1428W) WAS INTENDED TO BE USED AS A CONDUIT DURING A TAVI PROCEDURE. IT WAS NOTED THAT THE SENTRANT SHEATH WAS FREE FROM ANY DEFECTS. THE PATIENT PRESENTED WITH HYPOTENSION AND PERICARDIAL EFFUSION IT WAS REPORTED DURING THE INDEX PROCEDURE, THAT THE MEDICAL TEAM INADVERTENTLY PERFORATED THE LEFT VENTRICLE WHILE POSITIONING THE GUIDE WITHIN THE VENTRICLE. DESPITE EFFORTS, INCLUDING CARDIORESPIRATORY RESUSCITATION AND PERICARDIAL DRAINAGE, THE INTERVENTIONS WERE UNSUCCESSFUL, AND THE PATIENT EXPIRED DURING THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE PERFORATION AND SUBSEQUENT DEATH WAS DUE TO USER ERROR.

  Patient problems: Insufficient Information

  MAUDE report 21079100 ↗