GORE® DrySeal Flex Introducer Sheath GDSF2233Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132659012), received between Aug 20, 2025 and Sep 25, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient Device Interaction Problem

  The following information was reported to Gore:On (b)(6) 2026, this patient underwent an endovascular treatment for thoracoabdominal aortic aneurysm using GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE). A 22 Fr GORE® DrySeal Flex Introducer Sheath was inserted from the right superficial femoral artery. After implantation of the stent graft, the sheath was removed, and a dissection of the right common iliac artery was identified. As blood flow was not compromised, no treatment was performed, and the procedure was completed.The physician reported that the access vessel had a small diameter.

  Patient problems: Vascular Dissection

  MAUDE report 50893802 ↗
• InjuryAug 7, 2026No Apparent Adverse Event

  The following information was received from Clinical Complaint Specialist:On (b)(6)2026, the patient underwent endovascular procedure to treat a pararenal aneurysm at the descending thoracic aorta using a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) device system. A GORE® DrySeal Flex Sheath (DSF) was used for access.During the procedure, compartment syndrome of the left leg occurred. Left leg angiogram and fasciotomy occurred. This is reportedly attributed to the use of the DSF. This event is listed as ongoing.The procedure lasted about 5 hours and 15 minutes. Reportedly, the Left External Iliac Artery measured 10mm.

  Patient problems: Ischemia

  MAUDE report 50176142 ↗
• InjuryMar 12, 2026Use of Device Problem; Patient Device Interaction Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. ON (B)(6) 2026, THE PATIENT EXPERIENCED 500 ML BLOOD LOSS AND AN ACUTE POST-OP BLOOD LOSS ANEMIA AND HAD A BLOOD TRANSFUSION TREATMENT IN OPERATING ROOM. ON (B)(6) 2026, A LEFT AXILLARY HEMATOMA WAS NOTICED. BASED ON THE STUDY DATA, THE EVENT WAS POTENTIALLY RELATED TO DRYSEAL FLEX INTRODUCER SHEATH AND WAS FIXED DURING THE INITIAL PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PATIENT DIDN¿T HAVE A SIGNIFICANT AMOUNT OF BLOOD LOSS. PREOPERATIVELY, HGB WAS LOW AND WE TRANSFUSED TO KEEP HGB >9. TRANSFUSION WAS NOT DUE TO BLOOD LOSS. ACCORDING TO THE SITE, HEMATOMA WAS CAUSED BY THE ACCESSORY DEVICE. 100 ML BLOOD LOSS WAS FROM EVACUATED HEMATOMA AT LEFT AXILLARY AND WAS CAUSED BY THE ACCESSORY DEVICE. BASED ON THE INFORMATION PROVIDED, IT WAS UNCERTAIN WHERE ADDITIONAL 400ML BLOOD LOSS ORIGINATED FROM. DOCUMENTED IN OP NOTE EBL = TOTAL OF 500 ML. THE EVENT WAS RESOLVED. ACCORDING TO THE SITE, IT WAS PROCEDURE RELATED. THE PATIENT TOLERATED T

  Patient problems: Anemia; Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24585053 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ANEURYSM AT THE THORACOABDOMINAL AORTA USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM USING A GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON FOLLOW UP IMAGES ON (B)(6) 2025, REVEALED A RIGHT ILIAC ARTERY RETROGRADE DISSECTION. THE EVENT IS ONGOING, AND NO REINTERVENTION HAS BEEN PLANNED OR PERFORMED. REPORTEDLY THE DISSECTION WAS NOT PRESENT PRIOR TO THE PROCEDURE. THE CAUSE IS UNKNOWN. THERE IS NO ANEURYSM SAC ENLARGEMENT.

  Patient problems: Vascular Dissection

  MAUDE report 24488334 ↗
• InjuryFeb 4, 2026Partial Blockage; Patient Device Interaction Problem

  THE PHYSICIAN DOES NOT BELIEVE THAT GIVEN THE SIZE OF THE ACCESS COMMON FEMORAL ARTERY AND ILIAC VESSELS, THE DRYSEAL SHEATH CAUSED A COMPLETE OCCLUSION OF THE VESSEL. PARTIAL OCCLUSION OF THE VESSEL COULD HAVE CONTRIBUTED TO GETTING INTO THE MURAL THROMBUS EARLY BUT WHEN PULLED BACK, IT WAS IMPROVED.

  Patient problems: Ischemia; Reduced Blood Flow; Thromboembolism; Thrombosis/Thrombus

  MAUDE report 24262131 ↗
• InjuryFeb 3, 2026Obstruction of Flow; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM (UNKNOWN). ON (B)(6) 2025, THE PATIENT EXPERIENCED AN ACUTE BLOOD LOOS ANEMIA AND ON (B)(6) 2025 HAD A TREATMENT USING A UNIT OF PACKED RED BLOOD CELLS (PRBC). ON (B)(6) 2025, IT WAS NOTICED THAT THE PATIENT HAD A LOWER EXTREMITY REDUCED PERFUSION. IT WAS REPORTED THAT IT WAS POTENTIALLY RELATED TO A GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE PATIENT WAS TREATED BY 5000 UNITS HEPARIN IV, A LEFT COMMON FEMORAL ARTERY ENDARTERECTOMY AND 1 CM BOVINE PATCH. ON (B)(6) 2025, THERE WAS AN ACUTE KIDNEY INJURY NOTICED AND WAS TREATED BY COIL X 2 PLACEMENT IN PERFORATED BRANCH AND INTENTIONAL OCCLUSION OF THE LEFT RENAL ARTERY WITH A VASCULAR PLUG AND STENT. THE ISSUE WAS RELATED PROCEDURES. ON (B)(6) 2025, THE PATIENT HAD SPINAL CORD ISCHEMIA AND A BILATERAL LOWER EXTREMITY MOTOR LOSS WAS NOTED. THE PATIENT WAS TREATED BY THE LUMBAR DRAIN. ACCORDING TO THE SITE, IT WAS A PROCEDURE RELATED EVENT. ON (B)(6) 2025, THERE WERE LEFT RENAL INFARCT AND MULTIPLE ACUTE RIGHT RENAL CORTICAL INFARCTS. PROCEDURE RELATED. NO TREATMENT WAS REQUIRED. ON (B)(6) 202

  Patient problems: Ischemia; Movement Disorder; Paresis; Reduced Blood Flow

  MAUDE report 24254964 ↗
• InjuryAug 20, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM. GORE® DRYSEAL FLEX INTRODUCER SHEATH (GDSF) DEVICES WERE USED TO GAIN ACCESS DURING THE PROCEDURE. THE RIGHT-SIDE ACCESS WAS GAINED THROUGH A CUT-DOWN PROCEDURE. BECAUSE THE RIGHT EXTERNAL ILIAC ARTERY (REIA) WAS SMALL, A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY [PTA] WAS PERFORMED IN THE REIA. A GDSF2233 WAS THEN INTRODUCED ON THE RIGHT SIDE FOR INTRODUCTION OF THE TAMBE AORTIC COMPONENT. ALL DEVICES WERE DEPLOYED SUCCESSFULLY. ON (B)(6) 2025, 3 HOURS AFTER THE INDEX PROCEDURE, THE PATIENT WAS TREATED FOR COMPARTMENT SYNDROME RELATED TO THE IPSILATERAL (RIGHT) FEMORAL ARTERY. TREATMENT WAS LISTED AS "RIGHT LEG FASCIOTOMY WASH OUT AND MEDICAL FASCIOTOMY INCISION CLOSURE." ON (B)(6) 2025, THE PATIENT UNDERWENT A RIGHT LOWER EXTREMITY FASCIOTOMY WOUND EXPLORATION, LATERAL OPEN AND DURABLE NEGATIVE WOUND VACUUM-ASSISTED CLOSURE APPLICATION. THE PATIENT REMAINS HOSPITALIZED. ACCORDING TO THE PHYSICIAN, THE CAUSE OF THE COMPARTMENT SYNDROME WAS LIKELY DUE TO OCCLUSIVE

  Patient problems: Ischemia

  MAUDE report 22854609 ↗

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.