Sentrant™ SENSH2428W (UDI 00763000716295)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000716295), received between Apr 1, 2025 and Apr 1, 2025 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING A THORACIC AORTIC ENDOVASCULAR ISOLATION PROCEDURE, THE SENTRANT VASCULAR INTRODUCER SHEATH COULD NOT PASS THROUGH THE THORACIC AORTA STENT. THERE WAS DIFFICULTY IN WITHDRAWING THE STENT DELIVERY DEVICE WHICH WAS NOTED TO BE 24F IN DIAMETER, AND AN OBVIOUS CREASE WAS THEN OBSERVED ON THE SHEATH WHILE IN VITRO. THE HEALTHCARE PROFESSIONAL ATTEMPTED TO WITHDRAW THE STENT DELIVERY DEVICE, WHICH WAS CHALLENGING. AFTER FORCEFULLY PULLING THE THORACIC AORTIC STENT DELIVERY SYSTEM OUT OF THE SENTRANT SHEATH, THE STENT WAS SUCCESSFULLY DELIVERED USING A NON-MEDTRONIC LARGE SHEATH, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SENTRANT SHEATH ITSELF WAS NOT NOTED TO BE DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO DAMAGE NOTED ON THE DEVICE OR PACKAGING DURING PREP AND/OR UNBOXING. THE CAUSE OF THE CREASE ON THE SHEATH COULD NOT BE DETERMINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736803 ↗