GORE® DrySeal Flex Introducer Sheath GDSF1233Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132658893), received between Mar 24, 2025 and Sep 30, 2026 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K160254); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  Patient problems: Perforation of Vessels

  MAUDE report 50941531 ↗
• DeathOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED: ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS AND A GORE®DRYSEAL FLEX INTRODUCER SHEATH. IT WAS REPORTED THE PATIENT¿S ACCESS SITES WERE OUTSIDE OF INSTRUCTIONS FOR USE, THE ILIAC ARTERIES WERE SMALL (MEASUREMENT IS UNAVAILABLE) AND HIGHLY CALCIFIED. WHILE REMOVING THE GORE®DRYSEAL FLEX INTRODUCER SHEATH (DSF1233/(B)(6)) THE ILIAC ARTERY RUPTURED. THE PATIENT CODED, BLOOD LOSS WAS EXCESSIVE (AMOUNT IS UNKNOWN), AND BLOOD PRODUCTS WERE GIVEN DURING CARDIOPULMONARY RESUSCITATION (CPR). THE PATIENT EXPIRED.

  Patient problems: Vascular Dissection

  MAUDE report 23293157 ↗
• InjuryMar 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE (GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS) WAS IMPLANTED TO TREAT AN ANEURYSM, UTILIZING TWO 12FR SHEATHS. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WERE IMPLANTED AS BRANCH DEVICES. ON (B)(6) 2025, POST-PROCEDURE, A CT IMAGE REVEALED THE PATIENT DEVELOPED A TYPE 1B DISSECTION AROUND THE LEFT SUBCLAVIAN ARTERY (LSA). IT IS UNKNOWN WHICH 12FR SHEATH WAS USED IN THE LSA. ON THE SAME DAY, A REINTERVENTION SURGERY WAS PERFORMED, IN WHICH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS GRAFT DEVICE WAS IMPLANTED IN ZONE 2. THE CT IMAGING ALSO SHOWED THROMBOSED VBX STENTS THAT WERE IMPLANTED IN THE RIGHT RENAL ARTERY (RRA). DISTAL DISSECTION WAS ALSO NOTED FOR THE RRA. ON THE SAME DAY, THE DISSECTION AND THE THROMBOSED RRA STENTS WERE TREATED DURING THE INTERVENTION. THROMBECTOMY WAS DONE, AND A BARE METAL STENT WAS USED FOR 2CM DISTAL EXTENSION. THE IMPLANTED VBX STENTS WERE ALSO RELINED FOR RADIAL STRENGTH WITH IMPLANTATION OF A 7X79 VBX DEVICE. THE 6 X 79 VBX DEVICE WAS IMPLANTED MOST DISTAL IN THE RIGHT RRA. AS REPORTED, THE CAUSE OF THROMBOSIS IS UNKNOWN; HOWEVE

  Patient problems: Vascular Dissection

  MAUDE report 21684774 ↗
• InjuryMar 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE (GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS) WAS IMPLANTED TO TREAT AN ANEURYSM, UTILIZING TWO 12FR SHEATHS. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WERE IMPLANTED AS BRANCH DEVICES. ON (B)(6)2025, POST-PROCEDURE, A CT IMAGE REVEALED THE PATIENT DEVELOPED A TYPE 1B DISSECTION AROUND THE LEFT SUBCLAVIAN ARTERY (LSA). IT IS UNKNOWN WHICH 12FR SHEATH WAS USED IN THE LSA. ON THE SAME DAY, A REINTERVENTION SURGERY WAS PERFORMED, IN WHICH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS GRAFT DEVICE WAS IMPLANTED IN ZONE 2. THE CT IMAGING ALSO SHOWED THROMBOSED VBX STENTS THAT WERE IMPLANTED IN THE RIGHT RENAL ARTERY (RRA). DISTAL DISSECTION WAS ALSO NOTED FOR THE RRA. ON THE SAME DAY, THE DISSECTION AND THE THROMBOSED RRA STENTS WERE TREATED DURING THE INTERVENTION. THROMBECTOMY WAS DONE, AND A BARE METAL STENT WAS USED FOR 2CM DISTAL EXTENSION. THE IMPLANTED VBX STENTS WERE ALSO RELINED FOR RADIAL STRENGTH WITH IMPLANTATION OF A 7X79 VBX DEVICE. THE 6 X 79 VBX DEVICE WAS IMPLANTED MOST DISTAL IN THE RIGHT RRA. AS REPORTED, THE CAUSE OF THROMBOSIS IS UNKNOWN; HOWEVER

  Patient problems: Vascular Dissection

  MAUDE report 21684725 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160254. One submission often covers many models, so check the product and lot details in each record.

• Z-1962-2020 · Nov 18, 2019 · Terminated
  Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.