GORE® DrySeal Flex Introducer Sheath GDSF1633Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132658954), received between Dec 9, 2025 and Dec 9, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 9, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM, UTILIZING GORE® DRYSEAL FLEX INTRODUCER SHEATH. IT WAS REPORTED, DURING THE PROCEDURE. THERE WAS DIFFICULTY REMOVING THE SHEATH AFTER SUCCESSFULLY IMPLANTING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE FRONT PORTION OF THE SHEATH BROKE, ABOUT 3-5CM FROM THE TIP OF THE SHEATH. IT WAS ALSO REPORTED THE SHEATH WAS REMOVED WITH A CUTDOWN, AFTER IT SNAPPED WHILE ATTEMPTING TO REMOVE IT. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THE PHYSICIAN BELIEVES THE INTERACTION WITH THE PRO GLIDE (CLOSURE DEVICE) LIKELY CAUSED THE DIFFICULTY IN REMOVING THE SHEATH. CODE 5309-C: -ENDOVASCULAR INTER 1RY PROCEDURE: OTHER/UNKNOWN-USED TO CAPTURE CUTDOWN THAT WAS MADE IN ORDER TO REMOVE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759152 ↗

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.