GORE DRYSEAL FLEX Introducer Sheath DSF1265Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132628285), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (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.

• MalfunctionOct 4, 2021Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem

  THE FSA REPORTED: ON (B)(6) 2021, THE PATIENT WAS UNDERGOING A PROCEDURE TO REMOVE A PULMONARY EMBOLISM (PE). IT WAS REPORTED THAT THE FIRST ATTEMPT AT ACCESS WAS MADE WITH A COOK SHEATH AND THE PHYSICIAN COULD NOT ACCESS THE ARTERY. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF1265/22436982) WAS USED FOR ACCESS. THE PHYSICIAN WENT FROM THE INTERNAL JUGULAR (IJ) ARTERY TO GAIN ACCESS INTO THE PULMONARY ARTERY (PA). A PENUMBRA CATHETER WAS INSERTED INTO THE GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE PHYSICIAN REACHED A POINT OF RESTRICTION, THE PHYSICIAN KEPT PUSHING AND FORCED THE PENUMBRA CATHETER FURTHER IN UNTIL IT PERFORATED THE DSF SHEATH. UNDER FLUOROSCOPY IT WAS VISIBLE TO SEE A COMPLETE SEPARATION IN THE MIDDLE OF THE DSF SHEATH. ALL THE PIECES OF THE DSF SHEATH WERE THEN REMOVED. THE PE REMOVAL PROCEDURE WAS ABORTED. THE PATIENT IS WELL AND NEVER BECAME UNSTABLE.

  Patient problems: Embolism/Embolus; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572760 ↗

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.