GORE DRYSEAL FLEX Introducer Sheath DSF2065Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132628360), received between Sep 1, 2021 and May 10, 2026 — classified as 1 death, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2026Leak/Splash

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR TEVAR PROCEDURE IN THE DESCENDING THORACIC AORTA IN WHICH A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED AS AN ACCESSORY. REPORTEDLY, DURING PROCEDURAL SETUP, THE DRYSEAL SHEATH WAS PREPARED BY THE SCRUB NURSE. AFTER PREPARATION AND WHILE AWAITING RIGHT GROIN PUNCTURE, THE WHITE VALVE WAS OBSERVED TO HAVE DEFLATED. THE VALVE WAS REINFLATED WITH ADDITIONAL HEPARINIZED SALINE, AS IT WAS INITIALLY ASSUMED THAT THE VALVE MAY HAVE BEEN LEFT PARTIALLY OPEN. UPON ADVANCEMENT OF THE SHEATH INTO THE RIGHT COMMON FEMORAL ARTERY (CFA) GROIN, THE PHYSICIAN IMMEDIATELY NOTED THAT THE VALVE FAILED TO MAINTAIN INFLATION. AT THAT TIME, THE VALVE WAS SUSPECTED TO BE DAMAGED, WITH CONCERN FOR A HOLE IN THE VALVE. THE DILATOR WAS LEFT IN SITU WHILE A REPLACEMENT SHEATH WAS PREPARED. THE SUSPECT SHEATH WAS NOT USED FURTHER. A NEW SHEATH WAS PREPARED AND IMPLANTED WITHOUT ISSUE. ADDITIONALLY, NO ISSUES WERE REPORTED WITH THE 14FR SHEATH USED IN THE OTHER GROIN AND PROCEDURE COMPLETED SUCCESSFULLY. THE PHYSICIAN ATTRIBUTED THE DEVICE MALFUNCTION TO A HOLE IN THE VALVE. THERE WAS NO OBVIOUS FLUID, BUT OBVIOUS REDUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25133760 ↗
• InjuryAug 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE ON AUGUST 7, 2025, FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THIS 23-YEAR-OLD MALE PATIENT PRESENTED WITH A BLUNT AORTIC TRAUMATIC INJURY, INCLUDING BILATERAL OCCLUSION AND DISSECTION OF THE RIGHT AND LEFT COMMON ILIAC ARTERIES, UNDERWENT EMERGENCY ENDOVASCULAR PROCEDURE. THE PATIENT RECEIVED GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE), IMPLANTED IN ZONE 2 IN THE AORTIC ARCH, DELIVERED WITH A 20 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE DISSECTION OF THE COMMON ILIAC ARTERY WAS ADDRESSED WITH TWO KISSING STENTS USING TWO GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE. ONE ACCESS-RELATED COMPLICATION WAS NOTICED. THE PATIENT SUFFERED A LEFT EXTERNAL ILIAC ARTERY DISSECTION, ABOVE THE EPIGASTRIC ARTERIES, ASSOCIATED WITH THE 20 F GORE® DRYSEAL FLEX INTRODUCER SHEATH. THIS WAS NOTED TO BE RESOLVED BY STENTING OF THE EXTERNAL LEFT ILIAC ARTERY USING GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE.

  Patient problems: Vascular Dissection

  MAUDE report 22780895 ↗
• InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT TOTAL ARCH REPLACEMENT WITH LONG ELEPHANT TRUNK FOR AORTIC DISSECTION. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). WHEN THE DSF WAS INSERTED, IT WAS CAUGHT ON THE GREATER CURVATURE AND COULD NOT BE ADVANCED INTO THE ELEPHANT TRUNK. AT THAT TIME, VASCULAR INTIMA RUPTURE IN THE DISTAL AORTIC ARCH WAS SUSPECTED. NO SPECIFIC TREATMENT WAS PERFORMED FOR THE RUPTURE. THE PHYSICIAN SUGGESTED THAT THE INTIMA MAY HAVE RUPTURED WHEN THE DSF WAS INSERTED OR DURING THE PROCEDURE ON (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21248906 ↗
• InjurySep 6, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT A TEVAR PROCEDURE TO TREAT A ULP AND A THROMBUS IN THE THORACIC ARCH AORTA, WHICH WAS PERFORMED BEFORE TAVI PROCEDURE, USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. A 20FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY. THEN, TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM WERE DELIVERED THROUGH THE 20FR SHEATH AND IMPLANTED. AFTER ALL DEVICES WERE IMPLANTED, AN ANGIOGRAPHY AND IVUS REVEALED A DISSECTION AT THE RIGHT EXTERNAL ILIAC ARTERY. THIS DISSECTION WAS CONSIDERED TO OCCUR DUE TO THE 20FR SHEATH. A BARE METAL STENT WAS IMPLANTED IN THE RIGHT EXTERNAL ILIAC ARTERY TO TREAT THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, A DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY AROUND THE DISSECTION AREA WAS 6.5 ¿ 6.6 MM.

  Patient problems: Vascular Dissection

  MAUDE report 17691560 ↗
• DeathAug 10, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF A KINK OF PREVIOUS IMPLANTED FROZEN ELEPHANT TRUNK (FET) AND A THORACIC ANEURYSM ENLARGEMENT DUE TO A DISTAL TYPE I ENDOLEAK FROM FET. A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS DELIVERED USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF2065) WHICH WAS INSERTED FROM THE LEFT FEMORAL ARTERY. HOWEVER, IT WAS NOT ABLE TO PASS THROUGH THE KINK OF FET. THE CATHETER OF GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS REMOVED ONCE TO CHANGE THE APPROACH TO PULL-THROUGH FROM THE BRACHIAL ARTERY. THEN, THE KINK OF FET WAS RELEASED AND DISTAL END OF FET MIGRATED INTO THE ANEURYSM. THE PULL-THROUGH WAS CREATED AND DISTAL END OF FET WAS RELOCATED TO THE DESCENDING AORTA USING WIRE TENSION. THEN, THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED AS PLANNED. A FINAL ANGIOGRAPHY REVEALED NO ENDOLEAK. A SELECTIVE ANGIOGRAPHY WAS PERFORMED TO THE CELIAC ARTERY, THE SUPERIOR MESENTERIC ARTERY (SMA) AND THE RIGHT FEMORAL ARTERY TO CONFIRM WHETHER THE THROMBUS MIGRATION TO ABDOMINAL BRANCH VESSELS AND/OR LOWER LIMB OCCURRED DUE TO FET MIG

  Patient problems: Aneurysm

  MAUDE report 15199987 ↗
• InjurySep 1, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE¿ DRYSEAL FLEX INTRODUCER SHEATH (DSF) FOR THORACIC AORTIC ANEURYSM. THE PATIENTS ABDOMINAL AORTA HAD BEEN REPLACED TO Y-SHAPED GRAFT BEFORE THE PROCEDURE (DETAILS UNKNOWN). AN ATTEMPT WAS MADE TO INSERT 20FR 65CM SHEATH (DSF2065) FROM THE LEFT FEMORAL ARTERY, BUT THE DSF2065 STUCK AT THE ANASTOMOTIC SITE OF Y-SHAPED GRAFT. ATTEMPTS WERE MADE TO USE THE PULL-THROUGH WIRE TECHNIQUE AND DILATOR INSERTION, BUT THESE WERE UNSUCCESSFUL. IT WAS DECIDED TO EXCHANGE THE DSF2065 TO 20FR 33CM (DSF2033). THE DSF2065 WAS REMOVED, THEN BLOOD PRESSURE DECREASED AND VASCULAR DAMAGE WAS SUSPECTED. THE DSF2033 WAS ADVANCED, AND OCCLUSION WAS PERFORMED USING A BALLOON CATHETER. THE VITALS BECAME STABLE. THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED AND TWO STENT GRAFTS WERE DEPLOYED TO TREAT THE RUPTURE. THE PROCEDURE FOR THORACIC AORTIC ANEURYSM WILL BE PERFORMED IN THE FUTURE. THE PHYSICIAN STATED AS FOLLOWS; THE EVENT WAS EXPECTED. IT WAS A DIFFICULT CASE TO ACCESS, SO IT CAN'T BE HELPED.

  Patient problems: Vascular Dissection

  MAUDE report 12407299 ↗

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.