GORE DRYSEAL FLEX Introducer Sheath DSF1465Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132628308), received between Apr 1, 2022 and Dec 22, 2023 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Break; Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. REPORTEDLY, NEAR THE END OF THE PROCEDURE, THE DRYSEAL SHEATH WAS BROUGHT UP AND THRU THE VENOUS BIFURCATION WHERE THEY WERE UP AND OVER WITH EVERYTHING BEING FINE AT THAT POINT. THEN THEY BROUGHT UP THE PENUMBRA DEVICE WHICH WENT STRAIGHT THRU TO INFERIOR VENA CAVA (IVC) AS THEY WERE TREATING A CLOT AND THOUGHT IT WENT THRU THE SIDE WALL OF THE SHEATH BUT DETERMINED THAT THE SHEATH SPLIT IN HALF AT THE BIFURCATION AND WAS BEING HELD BY THE SHEATH COIL. THE PHYSICIAN USED A BALLOON TO PULL THE TWO PIECES (HALVES) OF THE SHEATH TOGETHER BY BRIDGING THEM AS ONE UNIT AND PULLED IT OUT OF THE PATIENT SAFELY. THERE WAS NO INJURY REPORTED TO THE PATIENT AND PHYSICIAN USED ANOTHER GORE SHEATH TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO PATIENT ANATOMY (TORTUOUS) ISSUE AND PHYSICIAN WAS SURPRISED THAT THE SHEATH BROKE LIKE THAT. THE FIELD SALES ASSOCIATE ARRIVED NEAR THE COMPLETION OF THE PROCEDURE AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387266 ↗
• DeathApr 1, 2022Difficult to Remove; Material Separation; Detachment of Device or Device Component; Difficult to Remove; Material Separation; Detachment of Device or Device Component

  ON (B)(6) 2022, THE PATIENT UNDERWENT AN EMERGENCY T- BRANCH THOROABDOMINAL ENDOVASCULAR PROCEDURE USING A GORE® VIABAHN® ENDOPROSTHESIS AND A GORE® DRYSEAL FLEX INTRODUCER SHEATH WITH THE ACCESS FROM THE AXILLARY ARTERY, THROUGH THE LEFT SUBCLAVIAN ARTERY (LSA) INTO THE DESCENDING AORTA. REPORTEDLY, THE SHEATH UNRAVELED INSIDE THE PATIENT AND BROKE WHEN THE PHYSICIAN TRIED TO TAKE IT OUT OF THE PATIENT. PART OF THE SHEATH REMAINED IN THE PATIENT AND EXTENDED FROM THE THORACIC AORTA TO THE ARCH. THE BROKEN PART OF THE SHEATH WAS SNARED AND PULLED OUT THROUGH THE SHEATH IN THE GROIN. IN ADDITION, THE LSA TORE, AND IT WAS REPAIRED BY A 10 X 4 VIABAHN. THE PATIENT ALSO DEVELOPED WHAT THE PHYSICIAN BELIEVED INITIALLY WAS A RETROGRADE DISSECTION FROM THE GRAFT TO THE LSA BUT UPON FURTHER REVIEW THE BROKEN SHEATH/ WIRE BRAID MAY HAVE CAUSED THE DISSECTION. THE PROCEDURE TOOK PROLONGED TIME. THE PROBLEM WAS DETECTED BY X-RAY BEING USED DURING THE ENDOVASCULAR PROCEDURE. THE PROCEDURE WAS COMPLETED BY STENTING A 9MM ATRIUM IN THE RENAL ARTERY AND WITH A DIFFERENT NON-GORE SHEATH. IT WAS REPORTED THAT THE DEVICE WAS PRE-TESTED PRIOR TO USE AND NO DAMAGE WAS NOTICED. THE SHEATH WAS USED ACCO

  Patient problems: Aneurysm; Stroke/CVA; Vascular Dissection

  MAUDE report 13972941 ↗

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.