GORE DRYSEAL FLEX Introducer Sheath DSF1665Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132628322), received between Jun 5, 2023 and Jun 30, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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.

• MalfunctionJun 30, 2023Material Frayed; Material Frayed

  ON (B)(6) 2023, THE PATIENT REPORTED EMERGENTLY TO THE EMERGENCY ROOM AS THE VICTIM OF A SERIOUS MOTORCYCLE CRASH. AS PART OF THE LIFESAVING MEASURE, A GORE® DRYSEAL FLEX SHEATH WAS INSERTED IN THE VENOUS JUGULAR IN PREPARATION FOR THE IMPLANT OF A PENUMBRA DEVICE. THE DILATOR WAS REMOVED, AND A WIRE WAS INSERTED. AT THIS TIME, THE SHEATH WAS INTERNALLY UNSUPPORTED. AS THE PATIENT CONTINUED TO DETERIORATE, PLANS TO INSERT A DEVICE THROUGH THE SHEATH WERE ABANDONED, AS THE PATIENT CRASHED SEVERAL TIMES. CHEST COMPRESSIONS WERE UTILIZED, AMONG OTHER MEASURES, BUT THE PATIENT EXPIRED. WHEN THE SHEATH WAS REMOVED, IT WAS SEEN THAT THE TIP HAD UNRAVELED. IT IS SUSPECTED THAT THIS OCCURRED AS A RESULT OF THE CHEST COMPRESSIONS. THE DEVICE WAS DISCARDED AT THE FACILITY, BUT IMAGES OF THE DEVICE WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17240887 ↗
• MalfunctionJun 5, 2023Material Separation; Material Separation

  ON MAY 8, 2023, THE GORE REPRESENTATIVE BECAME AWARE THAT THE LEADING END OF A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) HAD BROKEN DURING AN UNKNOWN PROCEDURE. THE GORE REPRESENTATIVE WAS NOT PRESENT AT THE CASE. NO PATIENT HARMS WERE REPORTED, AND ADDITIONAL CASE INFORMATION WAS UNAVAILABLE AND WILL NOT BE PROVIDED TO GORE. THE DSF WAS RETURNED FOR EVALUATION AND THE EVALUATION CONFIRMED THAT THE SHEATH WAS BROKEN APPROXIMATELY 5CM FROM THE LEADING END. THE ROOT CAUSE OF THE BROKEN SHEATH COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056961 ↗

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.