GORE DRYSEAL Sheath DSL2428Recalls & reported problems
W. L. Gore & Associates, Inc. · DRYSEAL LUBRICIOUS 24F Hydrophilic Coating · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132619993), received between Feb 4, 2020 and Feb 4, 2020 — classified as 1 death.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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
Device problems
- Patient-Device Incompatibility1
Patient problems
- Death1
- Perforation of Vessels1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathFeb 4, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO GORE THAT ON (B)(6) 2020, A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS WAS TO BE IMPLANTED DURING TREATMENT OF A THORACIC AORTA DISSECTION. WHEN THE DEVICE WAS ADVANCED TO THE TARGET LESION THROUGH THE GORE DRYSEAL SHEATH WITH HYDROPHILIC COATING(DSL2428), THE PHYSICIAN INITIATED THE DEPLOYMENT LINE, AFTER THE WHOLE DEPLOYMENT LINE WAS PULLED OUT, THE DEVICE EXPANDED SUCCESSFULLY, ONLY EXCEPT THAT ABOUT 3-4CM OF THE PROXIMAL END OF THE DEVICE COULDN¿T EXPAND. THE PHYSICIAN TRIED TO USE THE BALLOON(GORE TRI-LOBE BALLOON CATHETER) TO DILATE BUT THE BALLOON DIDN¿T GO THROUGH. THEN THE PATIENT WAS TRANSFERRED TO THE CARDIAC SURGERY DEPARTMENT FOR SURGICAL INTERVENTION. THE PHYSICIAN FOUND THE DEVICE AND CUT THE SEWN DEPLOYMENT SLEEVE. THE DEVICE EXPANDED AND THE DELIVERY CATHETER WAS RETRACTED. THE PATIENT¿S VITAL PRESSURE AND OTHER VITAL SIGNS WERE STABLE. THEN THE ABDOMINAL AORTIC DISSECTION AND LEFT ILIAC ARTERY DISSECTION WERE SEEN UNDER THE ANGIOGRAPHY. THE LIFETECH38-34-200(LOCAL BRAND) STENT WAS IMPLANTED IN DESCENDING AORTA. IT WAS SEEN THAT THE RIGHT COMMON ILIAC ARTERY WAS RUPTURED UNDER THE ANGIOGRAPHY BECAUSE OF PATIENT'S EXCESSIVE TORTUOUS VESSEL AND
Patient problems: Death; Perforation of Vessels
MAUDE report 9663466 ↗
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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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