GORE DRYSEAL FLEX Introducer Sheath DSF1045Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132628094), received between Apr 21, 2025 and Apr 21, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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.

• InjuryApr 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR TREATMENT DUE TO A POPLITEAL ARTERY ANEURYSM. AS REPORTED, THE PATIENT'S VESSEL WAS HEAVILY CALCIFIED. PRE-BALLOONING WAS NOT PERFORMED. ANTEGRADE ACCESS WAS MADE, A 10FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS PLACED AND THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS ADVANCED THROUGH THE SHEATH. HOWEVER, THE VIABAHN DEVICE DID NOT CROSS TO THE INTENDED TREATMENT SITE DUE TO THE CALCIFIED AREA AT THE PROXIMAL POPLITEAL ARTERY. DECISION WAS MADE TO WITHDRAW THE CONSTRAINED VIABAHN DEVICE BACK THROUGH THE SHEATH IN ORDER TO BALLOON THE TARGET LESION. HOWEVER, AS THE VIABAHN DEVICE WAS PULLED INTO THE SHEATH, THE DISTAL TIP GOT HUNG UP ON THE EDGE OF THE SHEATH. THE VIABAHN DEVICE WAS PULLED WITH EXTRA FORCE, CAUSING DEVICE DAMAGE. IT WAS REPORTED THE VIABAHN DEVICE WAS MANGLED DUE TO THE FORCE APPLIED. THE DEVICE AND SHEATH WERE REMOVED TOGETHER FROM THE PATIENT. AT THIS TIME IT WAS REALIZED THE COMMON FEMORAL ARTERY WAS PERFORATED. THE PATIENT WAS CONVERTED TO SURGICAL REPAIR. THE PATIENT WAS REPORTEDLY STABLE FOLLOWING THE SURGICAL INTERVENTION.

  Patient problems: Perforation of Vessels

  MAUDE report 21877665 ↗

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.