GORE DRYSEAL FLEX Introducer Sheath DSF2665Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132628421), received between Mar 7, 2019 and Oct 10, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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.

• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE), AND THE GORE® ASG DEVICE. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR AN AORTIC ANEURYSM INVOLVING THE VISCERAL VESSEL(S). IT WAS REPORTED ON (B)(6) 2024, THE PATIENT HAD A RIGHT BRACHIAL PSEUDOANEURYSM. THE SHEATH WAS USED IN THIS BRACHIAL ARTERY ON (B)(6) 2024, STUDY PROCEDURE. ON (B)(6) 2024, THERE WAS A REINTERVENTION. THE PHYSICIAN DID A CUTDOWN AND PRIMARY REPAIR. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Pseudoaneurysm

  MAUDE report 20424586 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT EMERGENCY TREATMENT OF A SYMPTOMATIC ZONE 0 DISSECTING ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH AND A GORE® TRI-LOBE BALLOON CATHETER WERE USED AS ACCESSORIES IN THE PROCEDURE. THE PATIENT'S ANATOMY WAS REPORTED TO BE EXTENSIVELY TORTUOUS. ON (B)(6) 2022, THE GORE REPRESENTATIVE WAS MADE AWARE THAT THE PATIENT HAD SPINAL CORD ISCHEMIA WHICH WAS OBSERVED ON THE EVENING OF THE INDEX PROCEDURE. IT WAS REPORTED THAT A NON-PROPHYLACTIC SPINAL DRAIN WAS PLACED POST-PROCEDURE AND A PLAN WAS MADE TO DISCHARGE THE PATIENT TO A REHAB CENTER. THE SPINAL CORD ISCHEMIA IS ONGOING. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS ARE IMPROVING.

  Patient problems: Ischemia

  MAUDE report 15592804 ↗
• MalfunctionFeb 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, DURING AN ENDOVASCULAR PROCEDURE WITH COOK DEVICES A BUDDY WIRE WAS RUN THROUGH A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). A NEEDLE WAS ALSO REPORTED TO HAVE BEEN ADVANCED WITHIN THE SHEATH. BLOOD LOSS COULD BE SEEN AND IT WAS REPORTED THAT THE NEEDLE HAD PUNCTURED THE BLADDER/TUBE OF THE SHEATH. THE SHEATH WAS REMOVED AND ANOTHER DSF WAS USED TO IMPLANT TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES. THE BLOOD LOSS WAS NOT SIGNIFICANT AND DID NOT REQUIRE TRANSFUSION OR CAUSE ANY HEMODYNAMIC IMPAIRMENT TO THE PATIENT. POST CONCLUSION OF THE GORE PORTION OF THE PROCEDURE THE GORE REPRESENTATIVE HAD LEFT THE OPERATING ROOM AND BECAME AWARE LATER THAT THE PATIENT HAD SUFFERED SEVERE BLOOD LOSS AND A DROP IN BLOOD PRESSURE AND HAD CODED. IT WAS REPORTED THAT THEY TRANSFUSED THE PATIENT WITH APPROXIMATELY 3 UNITS OF BLOOD AND WERE ABLE TO GET THE PATIENT BACK. NO FURTHER DETAILS WERE KNOWN AS TO PATIENT STATUS OR THE CAUSE OF THE CODE AT THE TIME THIS EVENT WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 13577881 ↗
• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE DEVICE): ON (B)(6) 2019, THE PATIENT UNDERWENT TREATMENT OF A BRACHIOCEPHALIC THORACIC AORTIC ANEURYSM IN ZONE 0/1 WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. AN AORTIC INTRODUCER SHEATH (DRYSEAL FLEX DSF2665/18570195) WAS USED IN THE LEFT FEMORAL ACCESS VESSEL. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED WITH A LEFT FEMORAL ACCESS VESSEL HEMATOMA. THE PHYSICIAN PERFORMED A LEFT GROIN WASHOUT AND REPAIR. THIS RESOLVED THE HEMATOMA, THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 8402346 ↗

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.