GORE® DrySeal Flex Introducer Sheath GDSF2433Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132659036), received between Jan 30, 2026 and May 22, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Fluid/Blood Leak

  ON (B)(6) 2026, DURING AN ENDOVASCULAR PROCEDURE, IT WAS REPORTED THAT A GORE® DRYSEAL FLEX INTRODUCER SHEATH (GDSF) WAS ADVANCED IN THE PATIENT AND WHEN TAKING THE DILATOR OUT A LEAK WAS DETERMINED. THE GDSF WOULDN'T HOLD ANY HEP SALINE EVEN AFTER INSERTING MORE WITH THE SYRINGE. THE GDSF WAS REMOVED AND EXCHANGED OUT BEFORE THE PROCEDURE CONTINUED AND BEFORE THE GRAFT WAS INSERTED. THE PATIENT TOLERATED THE PROCEDURE. THE DEFICIENT GDSF WAS DISCARDED AT THE SITE AND NOT AVAILABLE FOR EVALUATION BY GORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25261274 ↗
• InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2026, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS) USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® TRI-LOBE BALLOON CATHETER TO TREAT AN ASCENDING THORACIC DISSECTION. REPORTEDLY DURING THE PROCEDURE WHILE RETRACTING THE DELIVERY CATHETER OF THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER THE DEVICE MOVED DISTALLY AND PARTIALLY COVERED THE INNOMINATE ARTERY. THE PHYSICIAN IMPLANTED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS IN THE INNOMINATE ARTERY TO MAINTAIN PATENCY. THEN THE PHYSICIAN IMPLANTED A SECOND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER PROXIMALLY. THE PATIENT TOLERATED THE PROCEDURE. POST PROCEDURE IMAGES REVEALED A TYPE B DISSECTION FROM IMPLANTED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS AORTIC EXTENDER EXTENDING DOWN INTO THE ILIAC ARTERY. THE PHYSICIAN IS NOT TREATING THE DISSECTION AT THIS TIME. THE EVENT IS ONGOING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 24771037 ↗
• MalfunctionJan 30, 2026Fluid/Blood Leak

  THE FOLLOWING EVENT WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE VIA RIGHT INTERNAL JUGULAR ACCESS USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH FOR IMPLANTATION OF A NON-GORE DEVICE (MICRA¿ AV2 LEADLESS PACEMAKER). IT WAS REPORTED THAT THE HEMOSTATIC VALVE WAS PRESSURIZED DURING PREPARATION PRIOR TO INSERTION, WITH NO ISSUES NOTED. FOLLOWING INSERTION OF THE MICRA¿ AV2 DELIVERY SYSTEM INTO THE PATIENT, THE HEMOSTATIC VALVE WAS UNABLE TO MAINTAIN PRESSURE OR TIGHTEN AROUND THE DELIVERY SYSTEM, AND HEPARINIZED SALINE WAS OBSERVED LEAKING. THE REPORTER STATED THE LEAKAGE MAY HAVE BEEN DUE TO A TEAR IN THE HEMOSTATIC VALVE. DUE TO THE INABILITY TO RESTORE PRESSURIZATION, A REPLACEMENT SHEATH WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE, AND NO NEGATIVE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24223142 ↗

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.