Sentrant™ SENSH1628W (UDI 00763000716417)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000716417), received between Jan 26, 2026 and Jan 26, 2026 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 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.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  AN ETBF2813C124EJ STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 63MM AAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PATIENT HAD BARE-METAL STENTS PLACED FROM BOTH CIAS TO THE EIAS, WITH THE EIA OCCLUDED. ALTHOUGH STENOSIS WAS OBSERVED IN THE LEFT ACCESS, IT WAS DETERMINED THAT EVAR COULD PROCEED IF PTA WAS PERFORMED FIRST. AFTER APPLYING A 6MM PTA BALLOON TO THE LEFT ACCESS, AN ATTEMPT WAS MADE TO ADVANCE THE ETBF2813C124EJ FROM THE RIGHT ACCESS, BUT IT GOT STUCK AROUND THE CIA AND WAS DIFFICULT TO ADVANCE. IT WAS EVENTUALLY ADVANCED, AND THE MAIN BODY WAS DEPLOYED. AN NON-MEDTRONIC LIMB WAS PLACED ON THE CONTRALATERAL SIDE, DEPLOYED UP TO THE MAIN BODY ON THE IPSILATERAL SIDE, AND THEN REMOVED. DURING REMOVAL, ACCESS DAMAGE WAS A CONCERN, SO BLOOD PRESSURE WAS MONITORED. ALTHOUGH IT DROPPED SLIGHTLY, THE REPLACEMENT OF A SENTRANT SHEATH MADE IT UNCLEAR WHETHER DAMAGE HAD OCCURRED. AN NON-MEDTRONIC LIMB WAS PLACED ON THE IPSILATERAL DISTAL SIDE AND A TOUCH-UP WAS PERFORMED. FINAL ANGIOGRAPHY CONFIRMED THE ABSENCE OF ANY ENDOLEAK. A NON-MEDTRONIC SHEATH WAS INSERTED INTO THE LEFT FA WAS LOWERED TO THE FEMORAL HEAD AREA, AND ANGIOGRAPHY REVEALED A LOCALIZ

  Patient problems: Perforation of Vessels

  MAUDE report 24176301 ↗