Sentrant™ SENSH1228WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169792579), received between Mar 30, 2020 and Dec 19, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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.

• MalfunctionDec 19, 2022Delivered as Unsterile Product; Device Damaged Prior to Receipt by User; Delivered as Unsterile Product; Device Damaged Prior to Receipt by User

  A SENTRANT SHEATH WAS RECEIVED AND REVIEWED BY THE DISTRIBUTER. IT WAS REPORTED THAT UPON RECEIPT OF A SENTRANT SHEATH WITH LOT NUMBER: 00169045, THE DISTRIBUTER NOTED THAT UPON OPENING THE CARDBOARD TRANSPORT BOX, IT WAS FOUND THAT THE PACKAGING OF THE MATERIAL WAS DAMAGED, COMPROMISING ITS STERILITY. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16003643 ↗
• MalfunctionDec 9, 2020Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  A SENTRANT SHEATH WAS USED IN AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE SIDE PORT OF THE SHEATH FELL OFF AS A PIGTAIL CATHETER WAS BEING INSERTED. A NEW SHEATH WAS USED TO CONTINUE THE PROCEDURE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10975465 ↗
• MalfunctionMar 30, 2020Leak/Splash; Leak/Splash

  A SENTRANT SHEATH WAS INTENDED TO BE USED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT WHEN THE DEVICE WAS BEING PREPPED IT FAILED TO FLUSH. ANOTHER SHEATH WAS USED INSTEAD. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897568 ↗