GORE® DrySeal Flex Introducer Sheath GDSF2465Recalls & reported problems
W. L. Gore & Associates, Inc. · DrySeal Hydro Flex Sheath Ao 65cmx22Fr · Class 2
All models of GORE DRYSEAL FLEX Introducer Sheath (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132659043), received between Mar 6, 2026 and Mar 6, 2026 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Vascular Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 6, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2025, THE PATIENT WAS IMPLANTED WITH GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WHILE USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH TO TREAT A THORACIC ANEURYSM. IT WAS REPORTED THAT DURING THE ENDOVASCULAR PROCEDURE THERE WAS A RIGHT COMMON ILIAC ARTERY TEAR. BLEEDING FROM RIGHT COMMON ILIAC ARTERY WHERE THE VESSEL WALL TORE OVER THE CALCIFIED PLAQUE. DUE TO THIS, THE PATIENT WAS HYPOTENSIVE BRIEFLY AND REQUIRED A BLOOD TRANSFUSION. BLOOD LOSS -2000 UNITS. THE TEAR RESOLVED WITHOUT SEQUELAE. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: Unspecified Vascular Problem
MAUDE report 24533486 ↗
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 · TerminatedGore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
Other Introducer, catheter devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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