GORE® DrySeal Flex Introducer Sheath GDSF1245Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132658909), received between May 8, 2025 and May 8, 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.

• InjuryMay 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. ON (B)(6) 2025, A RIGHT UPPER EXTREMITY HEMATOMA WAS REPORTED. TREATMENT FOR THE HEMATOMA INCLUDED 25,000 UNITS OF CONTINUOUS HEPARIN VIA IV DRIP. ACUTE ANEMIA WAS REPORTED ON (B)(6) 2025. ON (B)(6) 2025, THE DACRON GRAFT THAT WAS IMPLANTED IN THE PATIENT'S RIGHT AXILLARY ARTERY WAS EXPLANTED DUE TO REPORTED OCCLUSION FROM THE HEMATOMA. A RIGHT AXILLARY ARTERY THROMBECTOMY AND A REDO OF THE RIGHT AXILLARY ARTERY TO BRACHIAL ARTERY BYPASS WITH REVERSE GREATER SAPHENOUS VEIN PROCEDURE WERE PERFORMED. ON (B)(6) 2025, ERYTHEMA OF THE RIGHT UPPER EXTREMITY WAS OBSERVED. CELLULITIS OF THE RIGHT UPPER EXTREMITY WAS ALSO REPORTED FROM THE LEVEL OF THE SHOULDER TO THE MID-DISTAL HUMERUS. THE PATIENT WAS STARTED ON CEPHALEXIN AND CEFEPIME. ON (B)(6) 2025, TREATMENT WAS PERFORMED WHEREBY RIGHT UPPER EXTREMITY IRRIGATION AND DEBRIDEMENT GREATER THAN 20CM WAS PERFORMED. A RIGHT UPPER EXTREMITY AXILLARY WOUND VAC WAS PLACED. ON

  Patient problems: Cellulitis; Drug Resistant Bacterial Infection; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21988220 ↗

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.