GORE DRYSEAL FLEX Introducer Sheath DSF1065Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132628261), received between Jan 13, 2021 and Mar 27, 2025 — classified as 3 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2025Break; Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, THE PATIENT WAS BROUGHT IN A FOR REINTERVENTION ON THE RIGHT SIDE WHERE THE CONTRALATERAL LEG (PXC141000) WAS IMPLANTED FOR A TYPE 1B ENDOLEAK WHICH WAS COIL EMBOLIZED THEN EXTENDED DISTALLY WITH A FLARED LIMB. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT AN COMMON AND INTERNAL ILIAC ANEURYSM UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. REPORTEDLY, THE MAIN BODY TRUNK IPSILATERAL GRAFT HAD MIGRATED DOWN BY 5CM FROM THE RENALS LEADING TO A TYPE 1B ENDOLEAK ON THE LEFT CONTRALATERAL (PXC201400) WITH ANEURYSM GROWTH IN THE COMMON ILIAC ARTERY (SIZE UNKNOWN). REINTERVENTION WAS DONE TO TREAT THE ENDOLEAK WITH IPSILATERAL IBE AND TO PRESERVE THE INTERNAL ILIAC ARTERY. DURING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE, A CONTRALATERAL SIDE UP AND OVER THE FLOW DIVIDER OF THE IBE DEVICE WAS DONE BY BASICALLY DELIVERING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) INTO THE DISTAL PART OF THE INTERNAL ILIAC ARTERY. THE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713780 ↗
• MalfunctionApr 22, 2022Difficult to Insert; Difficult to Insert

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: GREETINGS: I WANTED TO MAKE SURE THAT THIS OCCURRENCE WAS REPORTED. I JUST RECEIVED THE INFO: THE CASE DATE WAS (B)(6) 2022, (B)(6), PEDIATRIC PULMONARY CONDUIT STENT PLACEMENT, (B)(6) FEMALE. DRY SEAL FLEX LOT: 22470061. WHILE PLACING A PULMONARY CONDUIT STENT, THERE WAS RESISTANCE IN ADVANCING OR REMOVING THE STENT FROM THE SHEATH. THE SHEATH WAS REMOVED AND IT WAS SEEN THAT THE SHEATH HAD PULLED APART DISTALLY. THERE WERE NO ISSUES AND ANOTHER STENT WAS PLACED.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 14189921 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, DURING A REINTERVENTION PROCEDURE ON A PREVIOUSLY IMPLANTED COOK ZENITH DEVICE, A GORE® DRYSEAL 10FR SHEATH WAS USED DURING AN "UP AND OVER" PROCEDURE TO IMPLANT A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE. AFTER THE DEVICE WERE IMPLANTED, RESISTANCE WAS FELT DURING RETRACTION OF THE GORE® DRYSEAL 10FR SHEATH. MUCH FORCE WAS EXERTED TO TRY TO WITHDRAW THE SHEATH. FINALLY, THE SHEATH WITHDREW, HOWEVER, THE LEADING OLIVE BECAME DISLODGED FROM THE SHEATH AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN RETRIEVED THE OLIVE USING A SNARE. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT. EXCESSIVE TORTUOSITY WAS ALSO REPORTED, BUT THE PHYSICIAN DOES NOT BELIEVE TORTUOSITY WAS AN ISSUE WITH RETRACTION OF THE SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11164628 ↗

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.