GORE® DrySeal Flex Introducer Sheath GDSF1265Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132658916), received between Nov 11, 2025 and Nov 11, 2025 — classified as 1 malfunction.

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.

• MalfunctionNov 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2025, THE PATIENT WAS BEING TREATED IN THE AORTIC BIFURCATION FOR BILATERAL COMMON ILIAC ARTERY STENOSIS AND HYPOGASTRIC ARTERY STENOSIS, A GORE®DRYSEAL FLEX INTRODUCER SHEATH WAS BEING USED. IT WAS REPORTED THAT DURING A TWO-HOUR LONG PROCEDURE, APPROXIMATELY TEN MINUTES BEFORE FINISHING THE PROCEDURE, THE PHYSICIAN NOTICED THE GORE®DRYSEAL FLEX INTRODUCER SHEATH ¿APPEARED TO HAVE BEEN CUT, VERY CLEAN CUT¿. THERE WAS NO HARM TO THE PATIENT AND THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY THE SHEATH SHAFT WAS CUT IN THE MIDDLE. IT OCCURRED INSIDE THE PATIENT. A PENUMBRA SUCTION CATHETER SYSTEM (TO REMOVE THROMBUS IN ARTERY) AND TWO BOSTON SCIENTIFIC ANGIOPLASTY BALLOONS WERE USED AND WENT THROUGH THIS SHEATH. THE VBX DEVICES WERE ALREADY IMPLANTED, AND THE SHEATH WENT THROUGH THESE DEVICES. THE ROOT CAUSE OF THE SHEATH CUT IS UNKNOWN. THE FIELD SALES ASSOCIATE THEORIZED THAT IT POTENTIALLY OCCURRED WHEN ADVANCING THE SHEATH OVER THE BIFURCATION AND IT COULD HAVE CAUGHT UP ON THE IMPLANTED GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE.

  Patient problems: Stenosis

  MAUDE report 23528402 ↗

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.