GORE DrySeal Sheath SDV1828Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132612147), received between Sep 28, 2019 and May 1, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DISSECTION AT THE ABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. REPORTEDLY, DURING THE PROCEDURE, BETWEEN STENTING THE RIGHT AND LEFT RENAL ARTERIES, THE PATIENT DEVELOPED A DISSECTION THROUGHOUT THE THORACIC AORTA. THE CELIAC, SMA, AND RIGHT RENAL ARTERIES WERE ALL SUCCESSFULLY STENTED PRIOR TO THIS. THE PHYSICIANS ELECTED TO PLUG THE LEFT RENAL PORTAL AS THE LEFT RENAL ARTERY WAS NO LONGER FILLING. AN AORTIC EXTENDER WAS USED TO EXTEND THE TAMBE DEVICE DISTALLY AND SEAL IN THE PRIOR SURGICAL GRAFT. THE PROCEDURE WAS ABORTED, AND THE PATIENT WAS TAKEN FOR A STAT CT SCAN. THIS SHOWED A DISSECTION FROM THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY EXTENDING THROUGH THE TAMBE TREATMENT ZONE. THE TAMBE DEVICE WAS ALSO COMPRESSED FROM THE FALSE LUMEN. IT WAS REPORTED THAT THE PHYSICIANS FELT THIS WAS LIKELY DUE TO TRAUMA FROM THE AXILLARY SHEATH, WHICH WAS A (B)(6). THE PATIENT WAS TAKEN BACK TO THE OR FOR OPEN SURGICAL REPAIR. THE PATIENT RESPONDED WELL TO THE FROZEN ELEPHANT TRUNK (FET) OPEN CONVERSION. THE TRUE LUMEN OPENED UP AND DISTAL PU

  Patient problems: Vascular Dissection

  MAUDE report 25061856 ↗
• InjurySep 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2014 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH BECAME LOOSE REQUIRING REVISION AND ADDITIONAL MESH (B)(6) 2017. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available

  MAUDE report 9132481 ↗