GORE DRYSEAL FLEX Introducer Sheath DSF2233Recalls & reported problems

Summary

The FDA's MAUDE database contains 297 adverse event reports that list this exact device (DI 00733132630073), received between Aug 14, 2018 and Sep 30, 2026 — classified as 8 deaths, 282 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (126 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 25 most recent of 297 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 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). GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX) was used for the abdominal branch vessels. GORE® DrySeal Flex Introducer Sheath was used for delivery of the devices.After deployment of a VBX device in the superior mesenteric artery, vascular dissection was found distal to the VBX. It was treated and resolved by a softly inflated balloon.Additionally, during the procedure, vascular dissection of the left external iliac artery was reported. The cause of the dissection was not reported. The physician assessed causal relationship between the devices/procedure and the event as ¿unknown relationship.¿ No treatment was given for the access vessel dissection. As of September 7, 2026, the dissection was not resolved.

  Patient problems: Vascular Dissection

  MAUDE report 50942771 ↗
• InjurySep 29, 2026Patient Device Interaction Problem

  The following information was reported to Gore:On (b)(6) 2026, the patient underwent endovascular treatment of a thoracic aortic aneurysm in Zone 1.5 using GORE® TAG® Thoracic Branch Endoprosthesis.A 22 Fr GORE® DrySeal Flex Introducer Sheath was introduced from the patient¿s right side. Angiography performed after stent graft implantation revealed an access vessel injury involving the right external iliac artery. As a treatment, a stent graft was implanted in the right external iliac artery, and the sheath insertion site was additionally repaired surgically.Physician¿s comment: Resistance was encountered during the 22 Fr sheath insertion in relation to the right external iliac artery access vessel injury.

  Patient problems: Perforation of Vessels

  MAUDE report 50927182 ↗
• InjurySep 28, 2026Patient Device Interaction Problem

  The following was reported to Gore:On (b)(6) 2026, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm. A GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis, a GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System and four GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices were implanted using two GORE® DrySeal Flex Introducer Sheath (22Fr and 14Fr), a GORE® Tri Lumen Catheter and a GORE® Molding & Occlusion Balloon Catheter.The 22Fr GORE® DrySeal Flex Introducer Sheath was inserted from the left femoral artery and the 14Fr GORE® DrySeal Flex Introducer Sheath was inserted from the left axillary artery.After implantation of all devices, angiography revealed a rupture and dissection extending from the left external iliac artery to the left common femoral artery. A GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and a GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface were implanted in the left external iliac artery to treat the rupture. Subsequently, the 22 Fr GORE® DrySeal Flex Introducer Sheath inadvertently backed out. Two additional GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices were impla

  Patient problems: Embolism/Embolus; Ischemia; Perforation of Vessels; Vascular Dissection

  MAUDE report 50911703 ↗
• InjurySep 2, 2026Patient Device Interaction Problem

  On (b)(6), 2026, the patient underwent endovascular treatment for a descending aortic aneurysm. A GORE® DrySeal Flex Introducer Sheath (DSF sheath) was used for access. Reportedly, the DSF sheath was introduced through the right common femoral artery and advanced without any resistance. Access confirmation angiography was performed before removing the DSF sheath, and a dissection at the bifurcation of the iliac artery was suspected. A bare stent was placed from the right common iliac artery to the right external iliac artery. The patient tolerated the procedure.

  Patient problems: Vascular Dissection

  MAUDE report 50556563 ↗
• InjuryAug 4, 2026Patient Device Interaction Problem

  Patient problems: Vascular Dissection

  MAUDE report 50125609 ↗
• InjuryJul 30, 2026Difficult to Advance

  It was reported to Gore that, on (b)(6)2 026, the patient underwent Zone 2 endovascular treatment for a thoracic aortic aneurysm using the GORE® TAG® Thoracic Branch Endoprostheses and GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The GORE® DrySeal Flex Introducer Sheath and GORE® Molding & Occlusion Balloon Catheter were also used as accessories.A 22Fr sheath was inserted via the right common femoral artery; however, resistance was encountered at the right external iliac artery, preventing further advancement. Angioplasty of the common iliac artery and external iliac artery was performed using a PTA balloon, and sheath insertion was attempted again. Despite vessel dilation, the sheath could not be advanced beyond the right common iliac artery. Therefore, each device was advanced individually without the sheath. Subsequently, the CTAG and the Aortic Component were deployed, followed by deployment of the Side Branch Component in the left subclavian artery. Balloon dilation was then performed using the MOB balloon catheter.Access angiography demonstrated suspected pseudoaneurysm at the proximal portion of the right common iliac artery. However, no additional

  Patient problems: Pseudoaneurysm

  MAUDE report 50085820 ↗
• InjuryJul 30, 2026Patient Device Interaction Problem

  The following was reported to Gore:On (b)(6), 2026, the patient underwent endovascular treatment of a residual dissection in the thoracic aorta following total arch replacement and open stent grafting. Two GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System devices were implanted using a 22Fr GORE® DrySeal Flex Introducer Sheath.After removal of the 22Fr sheath, the left peripheral pulse was not palpable. Angiography, ultrasound, and IVUS revealed a dissection extending from the left external iliac artery to the left common femoral artery (puncture site).Reportedly, there was no significant difference in blood pressure between the right and left sides. Therefore, the physician decided to monitor the patient.It was reported that the vessel diameter from the left common femoral artery to the left external iliac artery ranged from approximately 6.2 to 9.5 mm.

  Patient problems: Vascular Dissection

  MAUDE report 50079123 ↗
• InjuryJul 7, 2026Difficult to Advance; Patient 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). GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS ALSO CONCOMITANTLY USED. THE PATIENT¿S RIGHT FEMORAL ARTERY (FA) AND RIGHT EXTERNAL ILIAC ARTERY (EIA) WERE SMALL IN DIAMETER (APPROXIMATELY 5 MM), WITH A MINIMUM EIA DIAMETER OF ABOUT 3.5 MM. THE LEFT EIA WAS THROMBOTICALLY OCCLUDED. ALTHOUGH THE RIGHT FA WAS STENOTIC, IT WAS NOT COMPLETELY OCCLUDED; THEREFORE, A GUIDEWIRE WAS SUCCESSFULLY ADVANCED AND THE VESSEL WAS DILATED WITH A BALLOON CATHETER. WHEN ATTEMPTING TO INSERT A 22 FR DSF SHEATH, RESISTANCE WAS ENCOUNTERED, SO THE SHEATH WAS ADVANCED USING A BALLOON-ASSISTED (BALLOON SWALLOW) TECHNIQUE. THE OCCLUDED SEGMENT OF THE LEFT EIA WAS ALSO RECANALIZED VIA A RIGHT-SIDED APPROACH, AND ACCESS WAS ESTABLISHED. ALL THE PLANNED DEVICES WERE SUCCESSFULLY DEPLOYED. THE SUPERIOR MESENTERIC ARTERY (SMA) WAS CHRONICALLY OCCLUDED, AND COLLATERAL FLOW FROM THE CELIAC ARTERY TO THE SMA HAD BEEN CONFIRMED; THEREFORE, THE SMA PORTAL OF THE TAMBE WAS EMBOLIZED USING A PLU

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 25728807 ↗
• InjuryJul 2, 2026Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC ARCH AORTIC ANEURYSM USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A NON-GORE STENT GRAFT (NAJUTA). IT WAS REPORTED THAT THE ACCESS VESSEL WAS NARROW. A 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT SIDE AND WAS ADVANCED APPROXIMATELY 5 CM FROM THE INSERTION SITE. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ATTEMPTED TO BE DELIVERED BUT CAUGHT ON THE RIGHT EXTERNAL ILIAC ARTERY. THE 22FR SHEATH WAS GRADUALLY COMING OUT; THEREFORE, IT WAS REINSERTED AND ADVANCED APPROXIMATELY 5 CM FURTHER THAN BEFORE, AND THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADVANCED AGAIN. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS ADVANCED TO THE INTENDED POSITION AND DEPLOYED SUCCESSFULLY. WHEN THE 22FR SHEATH WAS REMOVED, IT WAS OBSERVED THAT THE BLOOD PRESSURE GRADUALLY DECREASED. WHEN THE DELIVERY SYSTEM OF NAJUTA WAS INSERTED, THE BLOOD PRESSURE BECAME STABLE. THEREFORE, THE PROCEDURE WAS CONTINUED. AFTER NAJUTA WAS DEPLOYED PROX

  Patient problems: Perforation of Vessels

  MAUDE report 25687943 ↗
• InjuryJun 23, 2026Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. POST-DEPLOYMENT ACCESS ANGIOGRAPHY REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY. IN ADDITION, IT WAS CONFIRMED THAT BLOOD FLOW TO THE RIGHT INTERNAL ILIAC ARTERY WAS COMPROMISED POSSIBLY DUE TO THE FORMATION OF A FALSE LUMEN. NO ADDITIONAL INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS CONCLUDED WITH FOLLOW-UP OBSERVATION. THE OUTER DIAMETER OF THE 22FR SHEATH WAS 8.2 MM, WHILE THE ACCESS VESSEL DIAMETER WAS REPORTED TO BE 7.5¿8.0 MM.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 25603044 ↗
• MalfunctionJun 16, 2026Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS DEVICES AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. AN AORTIC COMPONENT (GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS) WAS IMPLANTED PROXIMALLY (ZONE 2), AND THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED DISTALLY (ZONE 3). RESISTANCE WAS ENCOUNTERED WHEN THE 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS ADVANCED. FRAYING (SPLINTER-LIKE DAMAGE) WAS OBSERVED AT THE LEADING END OF THE SHEATH. IT WAS REPORTED THAT WHILE A 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS BEING INSERTED, THE PHYSICIAN ATTEMPTED TO ENLARGE THE PUNCTURE SITE WITH A SCALPEL. DURING THIS PROCESS, THE SCALPEL CONTACTED THE DISTAL END OF THE SHEATH, WHICH MAY HAVE CAUSED THE OBSERVED FRAYING. THE 22FR SHEATH WAS REPLACED WITH ANOTHER 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. ALL DEVICES WERE SUCCESSFULLY IMPLANTED, AND NO ENDOLEAK OR VESSEL INJURY WAS OBSERVED. THE PROCEDURE WAS COMPLETED, AND THE PATIENT TOLERATED THE PROCEDURE WELL. TWO 22FR GORE® DRYSEAL FLEX INTRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25514545 ↗
• InjuryJun 10, 2026Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES. A 22FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE LEFT FEMORAL ARTERY AND TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES WERE IMPLANTED. AFTER ALL DEVICES WERE IMPLANTED, ANGIOGRAPHY OF THE ACCESS VESSEL REVEALED A DISSECTION IN THE LEFT COMMON ILIAC ARTERY NEAR THE BIFURCATION OF THE ILIAC ARTERY. THE PHYSICIAN DECIDED TO MONITOR THIS DISSECTION BECAUSE IT WAS MINOR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 25454648 ↗
• InjuryJun 2, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ARCH ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. REPORTEDLY, RESISTANCE WAS RESISTANCE DUE TO THE NARROW ACCESS VESSEL. A DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED ON THE ACCESS CONFIRMATION ANGIOGRAPHY. AN ADDITIONAL STENT GRAFT WAS PLACED TO TREAT THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 25357053 ↗
• InjuryMay 19, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED VIA THE RIGHT FEMORAL ARTERY. FOLLOWING DEPLOYMENT OF THE STENT GRAFT, ACCESS VESSEL ANGIOGRAPHY REVEALED A DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY, WHICH WAS CONSIDERED TO BE ASSOCIATED WITH SHEATH INSERTION. AS NO APPARENT COMPROMISE OF BLOOD FLOW WAS OBSERVED, THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL TREATMENT. IT WAS ALSO REPORTED THAT NO SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING SHEATH INSERTION.

  Patient problems: Vascular Dissection

  MAUDE report 25212100 ↗
• MalfunctionMay 15, 2026Material Split, Cut or Torn

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH AND ADVANCED THE DILATOR, WHICH ENCOUNTERED MILD RESISTANCE IN THE LEFT COMMON ILIAC ARTERY AS IT PASSED THROUGH THE EXISTING GORE® EXCLUDER® DEVICE. ALL VESSELS WERE PATENT; THE PATHWAY WAS SIMPLY TIGHT. THE PHYSICIAN CONTINUED ADVANCING THE DEVICE, AND THE DILATOR PASSED AN EXISTING BARE-METAL STENT IN THE PATIENT¿S LEFT RENAL ARTERY. UPON REMOVAL, THE DILATOR WAS FOUND TO BE SPLIT AT THE VERY PROXIMAL END OF THE TIP. DESPITE THIS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE SAME SHEATH, AND THE PATIENT TOLERATED THE PROCEDURE. AFTER REVIEWING THE PRE-OPERATIVE AND POST-OPERATIVE IMAGING, THE PHYSICIAN RECALLED SIGNIFICANT DIFFICULTY HAD BEEN ENCOUNTERED WHILE CANNULATING THE LEFT RENAL ARTERY. THE EXISTING BARE-METAL STENT WAS FOUND TO BE IN A DIFFERENT POSITION THAN EXPECTED. ALTHOUGH THE STENT HAD BEEN INTACT PRIOR TO THE PROCEDURE, IT APPEARED PARTIALLY CRUSHED AFTERWARD. IT IS BELIEVED THAT THE DILATOR CAUGHT ON THE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25192064 ↗
• InjuryMay 11, 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). GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS CONCOMITANTLY USED FOR THE PROCEDURE. AFTER SUCCESSFUL DEPLOYMENT OF ALL THE PLANNED DEVICES, AN ANGIOGRAPHY SHOWED VASCULAR DISSECTION ON THE RIGHT EXTERNAL ILIAC ARTERY. A SMART STENT (10 MM × 6 CM) WAS PLACED TO COVER THE DISSECTION. AFTER THAT, DISSECTION WAS ALSO FOUND ON THE RIGHT FEMORAL ARTERY. MISAGO STENTS (9 MM × 6 CM, 10 MM × 6 CM) WERE PLACED ON THE FEMORAL ARTERY THROUGH THE UPPER LIMB APPROACH. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: ALTHOUGH THERE WAS NO RESISTANCE DURING INSERTION OF THE SHEATH, IT WAS CONSIDERED THAT THE VASCULAR DISSECTION OCCURRED SINCE THE ACCESS VESSEL WAS TOO SMALL (6 MM TO 9 MM) FOR THE 22 FR SHEATH USE.

  Patient problems: Vascular Dissection

  MAUDE report 25133930 ↗
• InjuryApr 20, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF CHRONIC TYPE B AORTIC DISSECTION, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED VIA THE RIGHT ACCESS SITE. FOLLOWING STENT GRAFT IMPLANTATION, ACCESS VESSEL ANGIOGRAPHY REVEALED A LOCALIZED DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY, AS WELL AS VASCULAR INJURY DISTAL TO THE DISSECTION SITE. AS TREATMENT, A BARE METAL STENT WAS IMPLANTED AT THE SITE OF DISSECTION, AND A STENT GRAFT WAS PLACED AT THE SITE OF VASCULAR INJURY, AFTER WHICH THE PROCEDURE WAS COMPLETED. NO RESISTANCE WAS REPORTED DURING INSERTION OR REMOVAL OF THE SHEATH.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 24933896 ↗
• InjuryApr 16, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED VIA THE RIGHT-SIDED ACCESS; HOWEVER, RESISTANCE WAS ENCOUNTERED NEAR THE RIGHT EXTERNAL ILIAC ARTERY, AND INSERTION WAS NOT POSSIBLE. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS SUBSEQUENTLY PERFORMED FROM THE RIGHT COMMON ILIAC ARTERY TO THE RIGHT FEMORAL ARTERY. AFTER REATTEMPTING INSERTION OF THE SHEATH, RESISTANCE WAS STILL ENCOUNTERED AT THE LEVEL OF THE RIGHT EXTERNAL ILIAC ARTERY; HOWEVER, PASSAGE WAS POSSIBLE. FOLLOWING PASSAGE OF THE SHEATH, ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION AND POOLING OUTSIDE THE VESSEL NEAR THE RIGHT EXTERNAL ILIAC ARTERY, CONFIRMING VASCULAR INJURY. AS NO SIGNIFICANT HEMODYNAMIC CHANGES WERE OBSERVED, THE PLANNED STENT GRAFT IMPLANTATION WAS CONTINUED. DURING SHEATH REMOVAL AFTER COMPLETION OF STENT GRAFT IMPLANTATION IN THE THORACIC AORTA, AN ADDITIONAL STENT GRAFT WAS IMPLANTED FROM THE RIGHT COMMON ILIAC ARTERY TO THE RIGHT FEMORAL ARTERY. FINAL ACCESS VESSEL ANGIOGRAPHY CONFIRMED NO ABN

  Patient problems: Perforation of Vessels

  MAUDE report 24906069 ↗
• InjuryApr 8, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED THROUGH THE LEFT FEMORAL ARTERY. FOLLOWING DEPLOYMENT OF THE STENT GRAFT, ANGIOGRAPHY REVEALED A DISSECTION EXTENDING FROM THE LEFT COMMON ILIAC ARTERY TO THE LEFT EXTERNAL ILIAC ARTERY. AS A TREATMENT, A BARE-METAL STENT WAS PLACED FROM THE ORIGIN OF THE LEFT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING SHEATH INSERTION. THE SHEATH WAS ADVANCED AND RETRACTED MULTIPLE TIMES, AND THIS REPEATED MANIPULATION IS CONSIDERED THE MOST LIKELY CAUSE OF THE ILIAC DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 24812908 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT TO CLOSE THE PRIMARY ENTRY TEAR OF AN ACUTE TYPE B AORTIC DISSECTION. ON (B)(6) 2026, A SECONDARY TEVAR WAS PERFORMED TO CLOSE A THORACOABDOMINAL RE-ENTRY LOCATED DISTAL TO THE INITIAL TEVAR TREATMENT ZONE. A 22 GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED VIA THE LEFT COMMON FEMORAL ARTERY. AFTER STENT GRAFT PLACEMENT, ON ANGIOGRAPHY OF THE ACCESS, CONTRAST EXTRAVASATION WAS OBSERVED, AND INJURY TO THE LEFT EXTERNAL ILIAC ARTERY (EIA) WAS SUSPECTED. BLOOD TRANSFUSION WAS ADMINISTERED. THREE STENT GRAFTS WERE IMPLANTED FROM THE LEFT COMMON ILIAC ARTERY TO THE LEFT COMMON FEMORAL ARTERY, ACHIEVING HEMOSTASIS. PHYSICIAN¿S COMMENT: DURING SHEATH INSERTION, RESISTANCE WAS ENCOUNTERED AT A SINGLE SITE. A 22 FR SHEATH HAD ALSO BEEN USED DURING THE INDEX TEVAR, AND NO ISSUES WERE NOTED AT THAT TIME.

  Patient problems: Perforation of Vessels

  MAUDE report 24709354 ↗
• InjuryMar 19, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE 22 FR SHEATH WAS INTRODUCED VIA THE RIGHT FEMORAL ARTERY. USING THE RIBS TECHNIQUE, THE STENT GRAFT WAS DEPLOYED FROM THE ASCENDING AORTA. SUBSEQUENT ACCESS VESSEL ANGIOGRAPHY REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY. AS A TREATMENT, A BARE-METAL STENT WAS PLACED. FOLLOW-UP ANGIOGRAPHY DEMONSTRATED LOSS OF BLOOD FLOW TO THE RIGHT INTERNAL ILIAC ARTERY, BUT NO ADDITIONAL TREATMENT WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS APPROXIMATELY 6.8 TO 6.9 MM. THE ACCESS VESSEL DISSECTION WAS SUSPECTED TO HAVE BEEN CAUSED BY SHEATH MANIPULATION. THE LOSS OF PERFUSION TO THE RIGHT INTERNAL ILIAC ARTERY MAY HAVE RESULTED FROM THE DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY.

  Patient problems: Vascular Dissection

  MAUDE report 24636373 ↗
• InjuryMar 17, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED VIA THE LEFT FEMORAL ARTERY. AFTER SUCCESSFUL DEPLOYMENT OF THE STENT GRAFT, A DISSECTION OF THE LEFT EXTERNAL ILIAC ARTERY WAS IDENTIFIED. BASED ON THE PHYSICIAN¿S ASSESSMENT, THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL TREATMENT. THE DIAMETER OF THE DISSECTED VESSEL SEGMENT WAS REPORTED TO BE APPROXIMATELY 7.2 MM. PHYSICIAN¿S COMMENT: MILD RESISTANCE WAS ENCOUNTERED DURING THE INSERTION OF THE 22 FR SHEATH, AND IT IS POSSIBLE TO FORM OF THE DISSECTION DURING THE SHEATH INSERTION.

  Patient problems: Vascular Dissection

  MAUDE report 24624323 ↗
• InjuryMar 8, 2026Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED THORACIC AORTIC ANEURYSM DUE TO TYPE B AORTIC DISSECTION USING A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY, AND THEN THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED. AFTER THE STENT GRAFT WAS IMPLANTED, ACCESS ANGIOGRAPHY REVEALED A RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY. TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS LEGS WERE IMPLANTED TO COVER THE RUPTURED SITE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN STATED THAT THE 22 FR SHEATH HAD BEEN ADVANCED FORCIBLY. IT WAS REPORTED THAT THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS APPROXIMATELY 6 MM.

  Patient problems: Perforation of Vessels

  MAUDE report 24542085 ↗
• InjuryMar 2, 2026Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A 22 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE PATIENT¿S RIGHT SIDE FOR ACCESS. AFTER STENT GRAFT PLACEMENT, THE RIGHT ACCESS VESSEL INJURY WAS IDENTIFIED. AS TREATMENTS, TWO STENT GRAFTS WERE PLACED AT THE INJURED SEGMENT, FOLLOWED BY SURGICAL REPAIR TO ACHIEVE HEMOSTASIS. IT WAS REPORTED THAT THE DIAMETER OF THE INJURED VESSEL WAS APPROXIMATELY 7 MM. THE PHYSICIAN STATED THAT RESISTANCE WAS ENCOUNTERED DURING SHEATH INSERTION. PREOPERATIVELY, THE NARROWED ACCESS VESSEL HAD BEEN RECOGNIZED AS A POTENTIAL CONCERN.

  Patient problems: Perforation of Vessels

  MAUDE report 24480146 ↗
• InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE B AORTIC DISSECTION USING GORE TAG CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM, WITH THE GORE DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. ALTHOUGH EVAR FOR A RUPTURED ABDOMINAL AORTIC ANEURYSM HAD ALSO BEEN PLANNED, TEVAR AIMED AT REDUCING FALSE LUMEN PRESSURE WAS PRIORITIZED. A 22FR SHEATH WAS INSERTED FROM THE PATIENT¿S RIGHT SIDE, AND TWO CTAGS WERE DEPLOYED. ACCESS ANGIOGRAPHY REVEALED A SUSPECTED DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY; HOWEVER, NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24423245 ↗

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.