GORE DRYSEAL FLEX Introducer Sheath DSF2433Recalls & reported problems

Summary

The FDA's MAUDE database contains 152 adverse event reports that list this exact device (DI 00733132630950), received between Jul 12, 2018 and Jul 12, 2026 — classified as 7 deaths, 144 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (52 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 152 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 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. AN ATTEMPT WAS MADE TO INSERT A 24FR SHEATH VIA THE RIGHT FEMORAL ARTERY; HOWEVER, RESISTANCE WAS ENCOUNTERED. THEREFORE, ONLY THE DILATOR WAS ADVANCED, BUT RESISTANCE PERSISTED. UPON REMOVAL OF THE DILATOR, THE PATIENT DEVELOPED HYPOTENSION, AND INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY WAS IDENTIFIED. TEMPORARY OCCLUSION WAS PERFORMED USING A PTA BALLOON, FOLLOWED BY LAPAROTOMY. HEMODYNAMIC STABILITY WAS RESTORED BY CLAMPING THE PROXIMAL SIDE OF THE INJURY. AN APPROACH FROM THE ILIAC ARTERY SIDE WAS ATTEMPTED BUT DEEMED DIFFICULT, AND THE STRATEGY WAS CONVERTED TO AN AORTIC APPROACH. DEPLOYMENT OF THE STENT GRAFT WAS COMPLETED WITHOUT ISSUE. SUBSEQUENTLY, GRAFT REPLACEMENT OF THE INJURED SEGMENT OF THE RIGHT EXTERNAL ILIAC ARTERY WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 25791678 ↗
• InjuryJul 2, 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. RESISTANCE WAS ENCOUNTERED DURING THE INSERTION OF THE 24FR SHEATH. AFTER DEPLOYMENT OF THE STENT GRAFT AND REMOVAL OF THE SHEATH, A DISSECTION WAS IDENTIFIED AROUND THE AORTIC BIFURCATION AND THE RIGHT COMMON ILIAC ARTERY. ADDITIONALLY, DIMINISHED PALPABILITY OF PULSES IN THE RIGHT LOWER EXTREMITY AND DECREASED DOPPLER SIGNALS WERE NOTED; HOWEVER, THE PROCEDURE WAS COMPLETED WITH FOLLOW-UP OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Embolism/Embolus; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 25687300 ↗
• InjuryJun 26, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS. A 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED VIA THE LEFT FEMORAL ARTERY. FOLLOWING DEPLOYMENT OF THE STENT GRAFT, ACCESS VESSEL ANGIOGRAPHY REVEALED VESSEL DAMAGE IN THE LEFT EXTERNAL ILIAC ARTERY AND AT THE INSERTION SITE, WHICH WERE CONSIDERED TO BE ASSOCIATED WITH SHEATH INSERTION. A STENT GRAFT WAS PLACED TO TREAT THE VESSEL DAMAGE IN THE LEFT EXTERNAL ILIAC ARTERY, AND THE VESSEL DAMAGE AT THE INSERTION SITE WAS TREATED SURGICALLY. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE ACCESS VESSEL WAS NARROW.

  Patient problems: Perforation of Vessels

  MAUDE report 25632274 ↗
• InjuryMay 15, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ARCH ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A NON-GORE DEVICE. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. THE SHEATH WAS INTRODUCED FROM THE RIGHT SIDE. REPORTEDLY, PREOPERATIVE MEASUREMENTS REVEALED THAT A SEGMENT OF THE RIGHT ACCESS VESSEL HAD A DIAMETER OF APPROXIMATELY 6.8 MM. RESISTANCE WAS FELT DURING ADVANCEMENT OF THE SHEATH. A VESSEL RUPTURE WAS OBSERVED DURING THE ACCESS CONFIRMATION ANGIOGRAPHY. A STENT GRAFT WAS PLACED TO TREAT THE VESSEL RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN REPORTED THAT THE POSSIBILITY OF VESSEL INJURY DUE TO THE SMALL VESSEL DIAMETER WAS EXPECTED; HOWEVER, THE USE OF A LARGE-DIAMETER SHEATH WAS UNAVOIDABLE BECAUSE OF THE USE OF A NON-GORE DEVICE.

  Patient problems: Perforation of Vessels

  MAUDE report 25180198 ↗
• InjuryApr 30, 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 A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM AND A NON-GORE STENT GRAFT. A 24FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED FROM THE RIGHT FEMORAL ARTERY AND THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS IMPLANTED. WHEN A TOUCH-UP WAS PERFORMED, THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM WAS MOVED SLIGHTLY DISTALLY. THEN, THE NON-GORE STENT GRAFT WAS IMPLANTED PROXIMALLY. AFTER ALL DEVICES WERE IMPLANTED, A DISSECTION IN THE RIGHT COMMON ILIAC ARTERY TO THE RIGHT EXTERNAL ILIAC ARTERY WAS CONFIRMED. THERE WAS NO ISSUE ABOUT THE BLOOD FLOW OF THE DISTAL ARTERY OF THE DISSECTED SITE BY DOPPLER EXAMINATION. THE PROCEDURE WAS CONCLUDED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 25040963 ↗
• InjuryApr 27, 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 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INTRODUCED VIA THE RIGHT FEMORAL ARTERY. DURING INSERTION, RESISTANCE WAS ENCOUNTERED; HOWEVER, THE INSERTION WAS CONTINUED WITH FORCE. FOLLOWING DEPLOYMENT OF THE STENT GRAFT, ACCESS ANGIOGRAPHY WAS PERFORMED AND CONFIRMED REDUCED PERIPHERAL BLOOD FLOW FROM THE RIGHT FEMORAL ARTERY. SURGICAL CUTDOWN WAS SUBSEQUENTLY PERFORMED, WHICH REVEALED INTIMAL INJURY OF THE RIGHT FEMORAL ARTERY. A VASCULAR GRAFT REPLACEMENT WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED. THE PHYSICIAN MENTIONED THAT SEVERE CALCIFICATION OF THE RIGHT FEMORAL ARTERY WAS OBSERVED, WHICH LIMITED VASCULAR CONTROL, ALLOWING PLACEMENT OF ONLY ONE VESSEL LOOP.

  Patient problems: Perforation of Vessels

  MAUDE report 24994388 ↗
• InjuryApr 26, 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 THORACIC (ARCH) AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). WHEN ADVANCING A 24 FR DSF SHEATH, STRONG RESISTANCE WAS FELT DUE TO THROMBOTIC STENOSIS OF THE RIGHT EXTERNAL ILIAC ARTERY (DIAMETER 8.2 TO 10.6 MM), THOUGH THE SHEATH WAS ABLE TO BE ADVANCED TO THE TARGET AREA. AFTER ADVANCING THE PROXIMAL CTAG AC TO THE TARGET REGION, THE ALIGNMENT MARKER COULD NOT BE POSITIONED TOWARDS THE GREATER CURVE. SEVERAL ATTEMPTS TO REPOSITION THE DEVICE WERE MADE BUT NOT SUCCESSFUL. THE CTAG AC DEVICE WAS DEPLOYED AS IT WAS AND THE PROXIMAL END MOVED DISTALLY FOR APPROXIMATELY 5 MM. THERE WAS BIRD-BEAK CONFIGURATION AND IT WAS NOT RESOLVED BY OPTIONAL ANGULATION OF THE CTAG AC. THE FINAL ANGIOGRAPHY SHOWED A TYPE IA ENDOLEAK AND IT WAS LEFT FOR MONITORING. AFTER REMOVING THE DSF SHEATH, VASCULAR INJURY OF THE RIGHT EXTERNAL ILIAC ARTERY WAS FOUND. ADDITIONAL COVERED STENTS WERE PLACED TO TREAT THE INJURY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 24993940 ↗
• InjuryMar 31, 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 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED THROUGH THE LEFT FEMORAL ARTERY. FOLLOWING SUCCESSFUL DEPLOYMENT OF THE STENT GRAFTS, THE SHEATH WAS REMOVED. DURING SHEATH REMOVAL, VASCULAR INJURY AT THE INSERTION SITE WAS IDENTIFIED. SURGICAL REPAIR WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THE PHYSICIAN MENTIONED THAT THIS COMPLICATION WAS UNAVOIDABLE DUE TO THE SMALL DIAMETER OF THE ACCESS VESSEL.

  Patient problems: Perforation of Vessels

  MAUDE report 24750356 ↗
• InjuryMar 23, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2026, A 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) WAS UTILIZED FOR A THORACIC ENDOVASCULAR REPAIR. DURING THE PROCEDURE, THE VALVE OF THE DSF REPORTEDLY BROKE, RESULTING IN BLEEDING. A DEVICE OF AN UNKNOWN BRAND WAS ADVANCED THROUGH THIS SHEATH BUT COULD NOT BE RETRIEVED, PREVENTING THE ADVANCEMENT OF THE DILATOR TO STOP THE BLEEDING. TWISTING THE VALVE ALSO SEEMED NOT TO WORK DUE TO THE DAMAGE TO THE VALVE. THE PATIENT REQUIRED BLOOD TRANSFUSION (VOLUME NOT SPECIFIED). A NEW DSF WAS USED INSTEAD THE PROCEDURE WAS SUBSEQUENTLY COMPLETED WITHOUT FURTHER REPORTED COMPLICATIONS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24660465 ↗
• InjuryJan 29, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DESCENDING AORTA ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. THE SHEATH WAS INTRODUCED FROM RIGHT SIDE. WHILE ADVANCING THE SHEATH, IT BECAME DIFFICULT TO ADVANCE NEAR THE BIFURCATION OF THE INTERNAL AND EXTERNAL ILIAC ARTERIES. AFTER REPEATEDLY PUSHING AND PULLING THE SHEATH SEVERAL TIMES, VASCULAR INJURY WAS CONFIRMED ON AN ANGIOGRAPHY. AFTER ALL STENT GRAFTS WERE PLACED, AN ADDITIONAL STENT GRAFT WAS PLACED TO TREAT THE VESSEL INJURY. THE PATIENT TOLERATED THE PROCEDURE. THE ACCESS VESSEL WAS REPORTEDLY NARROW AND CALCIFIED.

  Patient problems: Perforation of Vessels

  MAUDE report 24206844 ↗
• InjuryJan 15, 2026Patient Device Interaction Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DESCENDING AORTA ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. THE SHEATH WAS INTRODUCED FROM LEFT SIDE. IT WAS REPORTED THAT A STRONG RESISTANCE WAS FELT WHILE ADVANCING THE SHEATH. AFTER ALL STENT GRAFTS WERE PLACED, A DISSECTION IN THE LEFT EXTERNAL ILIAC ARTERY WAS OBSERVED. A BARE STENT WAS PLACED TO TREAT THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE DIAMETER OF THE ACCESS VESSEL WAS BETWEEN 7.0 TO 8.6MM.

  Patient problems: Vascular Dissection

  MAUDE report 24077621 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM WITH DISSECTION USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE 24 FR SHEATH WAS INSERTED VIA THE LEFT COMMON FEMORAL ARTERY. AFTER STENT GRAFT PLACEMENT IN THORACIC AORTA, ANGIOGRAPHY OF THE ACCESS VESSEL REVEALED VASCULAR INJURY IMMEDIATELY PROXIMAL TO THE SHEATH INSERTION SITE. AS BLOOD PRESSURE GRADUALLY DECREASED, THE VESSEL OCCLUSION WAS PERFORMED USING A GORE® MOB BALLOON CATHETER, AND GORE® EXCLUDER®AAA ENDOPROSTHESIS WAS DEPLOYED AT THE SITE OF INJURY. UPON REMOVAL OF THE MOB CATHETER, THE PREVIOUSLY PLACED EXCLUDER LEG MIGRATED DISTALLY. WHEN THE SHEATH WAS WITHDRAWN, THE DISTAL END OF THE MIGRATED LEG BECAME EXPOSED FROM THE PUNCTURE SITE, RESULTING IN MASSIVE BLOOD LEAKAGE FROM THE LEG. THE BLOOD PRESSURE DROPPED TO AROUND 40, AND AN EMERGENCY BLOOD TRANSFUSION WAS REQUIRED. THE DISTAL END OF THE LEG WAS CLAMPED, AND THE BALLOON OCCLUSION WAS PERFORMED VIA A CROSSOVER APPROACH/FROM THE RIGHT SIDE TO ALLOW PLACEMENT OF A SECOND EXCLUDER LEG. THE FIRST EXCLUDER LEG WAS REMOVED EXTERNALLY USING FORCEPS. THE INTIMA WAS REPAIRED, AND

  Patient problems: Perforation of Vessels

  MAUDE report 23824871 ↗
• InjuryDec 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A SUSPECTED RUPTURE OF AN ANEURYSM AT THE PROXIMAL ANASTOMOSIS SITE FOLLOWING THORACOABDOMINAL AORTIC REPLACEMENT THAT WAS PERFORMED IN 2019. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS USED FOR ACCESS. A VESSEL DAMAGE IN THE RIGHT EXTERNAL ILIAC ARTERY WAS OBSERVED WHILE REMOVING THE DSF SHEATH. AN ADDITIONAL STENT GRAFT WAS PLACED TO TREAT THE VESSEL DAMAGE BUT BLEEDING CONTINUED. A DISSECTION AT THE PUNCTURE SITE WAS CONFIRMED AND WAS TREATED BY SURGICALLY. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE ACCESS VESSEL DIAMETER WAS APPROXIMATELY 6MM, AND CALCIFICATION WAS PRESENT.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 23753346 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE5 DESCENDING THORAC AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM DEVICES. A 24 FR GORE® DRYSEAL HYDRO FLEX INTRODUCER SHEATH WHICH WAS SUCCESSFULLY USED TO DELIVER THE DEVICE(S) AND THEN REMOVED FROM THE PATIENT. AT THIS TIME, THE PATIENT¿S PRESSURE STARTED TO DROP. THE PHYSICIAN GAINED ACCESS FROM THE LEFT GROIN AND AN ANGIOGRAM WAS COMPLETED AND EXTRAVASATION WAS OBSERVED FROM THE RIGHT COMMON FEMORAL ARTERY (RCFA). THE PHYSICIAN USED AN UP AND OVER TECHNIQUE TO DELIVER THREE (NON-GORE) BALLOON EXPANDABLE STENTS FROM THE RCFA TO THE RIGHT COMMON ILIAC ARTERY (RCIA). THE PATIENT¿S VITALS THEN RETURNED TO NORMAL. THE PHYSICIAN WAS SATISFIED AND THE CASE WAS COMPLETED. IT IS BELIEVED THAT THE SMALL SIZE OF THE PATIENT¿S RCFA WAS THOUGHT TO HAVE CAUSED/CONTRIBUTED TO A TEAR OF THE AREA DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 23751476 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACIC (ARCH) AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC), GORE® DRYSEAL FLEX INTRODUCER SHEATH AND GORE® TRI-LOBE BALLOON CATHETER. TOTAL ARCH REPLACEMENT WAS ALSO PERFORMED SIMULTANEOUSLY. THE CTAG AC DEVICES WERE DELIVERED IN ANTEGRADE MANNER OVER A PULL-THROUGH GUIDEWIRE FROM THE THORACIC AORTA TO THE LEFT FEMORAL ARTERY. TWO CTAG ACS WERE SUCCESSFULLY DEPLOYED. AFTER CLOSURE OF THE SURGICAL INCISION, IMPAIRMENT BLOOD FLOW IN THE RIGHT LOWER LIMB WAS FOUND. THROMBECTOMY WITH FOGARTY CATHETER WAS PERFORMED AND THE BLOOD FLOW WAS RESTORED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: MICRO THROMBUS DISLODGEMENT DURING THE PROCEDURE WAS A POSSIBILITY. THE TIMING OF THROMBUS DISLODGEMENT WAS UNKNOWN (INSERTION OF GUIDEWIRE, SHEATH, OR DEVICES, OR ANASTOMOSIS).

  Patient problems: Embolism/Embolus

  MAUDE report 23739886 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG). THE PATIENT¿S ABDOMINAL AORTA HAD BEEN REPLACED WITH A Y-SHAPED SYNTHETIC GRAFT, AND A 10 MM DIAMETER SYNTHETIC GRAFT (MANUFACTURER UNKNOWN) WAS USED AS A CONDUIT. ON AN UNKNOWN DATE, ENLARGEMENT OF THE VESSEL DIAMETER AT THE DISTAL END OF THE PREVIOUSLY IMPLANTED CTAG WAS OBSERVED. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION. (ADDRESSED IN #2017233-2025-06848.) THE LIGATED PORTION OF THE PREVIOUS CONDUIT WAS TRANSECTED AND ANASTOMOSED TO A NEW SYNTHETIC GRAFT (MANUFACTURER UNKNOWN). UPON INSERTION OF A 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), RESISTANCE WAS ENCOUNTERED NEAR THE ANASTOMOSIS BETWEEN THE Y-SHAPED SYNTHETIC GRAFT AND THE PREVIOUS CONDUIT, AND THE DSF WAS ADVANCED THROUGH THE SITE WITH APPLIED FORCE. THE FIRST CTAG WAS DEPLOYED DISTALLY, BUT ITS DISTAL END WAS POSITIONED MORE PROXIMALLY THAN INTENDED. AFTER DEPLOYING THE SECOND CTAG, A DISTAL TYPE I ENDOLEAK WAS OBSERVED. A TOUCH-UP PROCEDURE WAS PERFORMED, RESULTING IN A SLIG

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23610041 ↗
• InjuryNov 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. WHEN INSERTING A 24FR SHEATH VIA THE PATIENT¿S RIGHT ACCESS SITE, RESISTANCE WAS ENCOUNTERED, AND ANGIOGRAPHY OF THE ACCESS VESSEL REVEALED VASCULAR INJURY NEAR THE RIGHT EXTERNAL ILIAC ARTERY EXTENDING TO THE RIGHT COMMON FEMORAL ARTERY. AS A TREATMENT, GORE® EXCLUDER®AAA ENDOPROSTHESIS (PLC121400J) WAS IMPLANTED AT THIS SITE. AFTER REPAIRING THE VASCULAR INJURY, WHEN THE SHEATH WAS REINSERTED, THE EDGE OF THE PREVIOUSLY IMPLANTED LEG COMPONENT BECAME CAUGHT, CAUSING PROXIMAL MIGRATION. CONSEQUENTLY, AN ADDITIONAL STENT GRAFT WAS IMPLANTED DISTALLY. AFTER CONFIRMING THAT THE PATIENT¿S VITAL SIGNS WERE STABLE, THE SHEATH WAS DELIVERED AND STENT GRAFTS WERE DEPLOYED IN THE DESCENDING AORTA, AND THE PROCEDURE WAS COMPLETED. THE DIAMETER OF THE NARROWED SEGMENT OF THE RIGHT ACCESS VESSEL WAS REPORTED TO BE APPROXIMATELY 6.8 MM. THE PHYSICIAN MENTIONED THAT THE ACCESS WAS NARROW AND SHOWED SIGNIFICANT CALCIFICATION, SO THE VASCULAR INJURY WAS ANTICIPATED.

  Patient problems: Perforation of Vessels

  MAUDE report 23601697 ↗
• InjuryNov 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. A 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED VIA THE RIGHT FEMORAL ARTERY. AFTER PLACEMENT OF THE STENT GRAFT AND REMOVAL OF THE SHEATH, RESISTANCE WAS ENCOUNTERED. AS BLOOD PRESSURE DROPPED SIMULTANEOUSLY WITH THE SHEATH REMOVAL, ANGIOGRAPHY WAS PERFORMED, REVEALING AN INJURY TO THE RIGHT EXTERNAL ILIAC ARTERY. A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS IMPLANTED TO ACHIEVE HEMOSTASIS. THE VESSEL DIAMETER AT THE SITE OF INJURY WAS REPORTEDLY APPROXIMATELY 8.2 MM.

  Patient problems: Perforation of Vessels

  MAUDE report 23565830 ↗
• InjuryNov 13, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, DURING AN INDEX PROCEDURE OF AN ANEURYSM REPAIR, A PATIENT SUFFERED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY (EIA) WITH ACUTE ISCHEMIA, RELATED TO THE USE OF A GORE® DRYSEAL FLEX INTRODUCER SHEATH. THE PATIENT UNDERWENT ON (B)(6) 2025, RESECTION OF THE COMMON FEMORAL ARTERY AND THE RIGHT EIA WITH RETROGRADE STENTING IN THE RIGHT EIA. THE PATIENT RECOVERED.

  Patient problems: Ischemia; Vascular Dissection

  MAUDE report 23546793 ↗
• InjuryNov 3, 2025Off-Label Use; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A PLANNED THORACIC ENDOVASCULAR AORTIC REPAIR. THE PROCEDURE WAS INITIATED, AND THE PHYSICIAN DECIDED TO USE THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF2433, SN: (B)(6) IN A VERY SMALL ACCESS SITE. REPORTEDLY, THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS 5.5 MM, AND THE DIAMETER OF THE RIGHT COMMON ILIAC ARTERY WAS 7 MM. THE PHYSICIAN ADVANCED THE DSF SHEATH UP TO THE AORTIC BIFURCATION AND SUCCESSFULLY IMPLANTED ALL PLANNED DEVICES. AT THE CONCLUSION OF THE IMPLANTATION, UPON WITHDRAWAL OF THE DSF SHEATH, ANGIOGRAPHY REVEALED A RUPTURE OF THE ILIAC VESSELS. THE RUPTURE WAS MANAGED USING A GORE® VIABAHN® ENDOPROSTHESIS AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS - CONTRALATERAL LEG COMPONENT, PLC121000. ADDITIONALLY, A RUPTURE AT THE RIGHT COMMON FEMORAL ARTERY WAS OBSERVED WITH UNKNOWN CAUSE. THE PHYSICIAN OPTED TO USE A VASCULAR GRAFT TO REPAIR THE RUPTURE, WHICH WAS SUCCESSFULLY IMPLANTED. THE CAUSE OF THE RUPTURE IN THE COMMON FEMORAL ARTERY WAS REPORTEDLY NOT BY THE DSF REMOVAL ACTION. A BLOOD TRANSFUSION WAS ALSO REQUIRED, ALTHOUGH THE VOLUME OF BLOOD LOSS DURING THESE EVENTS WAS NOT SPECIFIED. THE PATIE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 23447073 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 2 THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) DEVICES AND A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG-AC) DEVICES. THE PHYSICIAN NOTED THE PATIENT¿S SMALLER ACCESS VESSELS WITH A DIAMETER OF 7.5 OR SO AND SERIAL DILATED THE ACCESS VESSELS PRIOR TO ADVANCEMENT OF A 24 FR GORE® DRYSEAL HYDRO FLEX INTRODUCER SHEATH WHICH WAS SUCCESSFULLY USED TO DELIVER THE DEVICE(S) WITHOUT ISSUE. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD TECHNICAL SUCCESS. LATER THIS SAME DAY IT WAS REPORTED THAT THE PATIENT HAD REQUIRED RECONSTRUCTION OF THE LEFT SIDE ACCESS VESSELS, AND THE PHYSICIAN PERFORMED A FEM FEM BYPASS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342479 ↗
• InjuryOct 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A SUBACUTE TYPE B AORTIC DISSECTION AND THORACIC AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. A 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED VIA THE LEFT COMMON FEMORAL ARTERY, BUT SIGNIFICANT RESISTANCE WAS ENCOUNTERED. THE SHEATH WAS ADVANCED TO THE TARGET LESION, AND TWO CTAG DEVICES WERE SUCCESSFULLY IMPLANTED IN THE DESCENDING THORACIC AORTA. RESISTANCE WAS AGAIN NOTED DURING SHEATH REMOVAL. A DILATOR WAS INSERTED, AND THE SHEATH WAS SLOWLY WITHDRAWN. HOWEVER, WHEN THE SHEATH WAS PULLED BACK TO THE LEVEL OF THE LEFT EXTERNAL ILIAC ARTERY, THE PATIENT BLOOD PRESSURE DROPPED. ANGIOGRAPHY REVEALED EXTRAVASATION OF CONTRAST, INDICATING VASCULAR INJURY AND BLEEDING. TO CONTROL THE BLEEDING, BALLOON OCCLUSION WAS PERFORMED IN THE LEFT COMMON ILIAC ARTERY, AND TWO GORE® EXCLUDER®AAA ENDOPROSTHESIS LEGS WERE DEPLOYED FROM THE LEFT COMMON ILIAC ARTERY TO THE LEFT EXTERNAL ILIAC ARTERY. HOWEVER, IT WAS REVEALED THAT THE VASCULAR INJURY HAD EXTENDED DISTALLY TO THE LEFT COMMON FEMORAL ARTERY. A OPEN SURGICAL REPAIR WA

  Patient problems: Perforation of Vessels

  MAUDE report 23334273 ↗
• InjuryOct 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM, ZONE 2, USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. A 24 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS INSERTED VIA THE RIGHT COMMON FEMORAL ARTERY. AFTER PLACEMENT OF THE STENT GRAFT AND REMOVAL OF THE SHEATH, AN ACCESS INJURY WAS IDENTIFIED A FEW CENTIMETERS PROXIMAL TO THE PUNCTURE SITE IN THE RIGHT COMMON FEMORAL ARTERY. AS A TREATMENT, VASCULAR GRAFT REPLACEMENT WAS PERFORMED. THE DIAMETER OF THE RIGHT ACCESS VESSEL WAS APPROXIMATELY 7.8 MM TO 9.2 MM.

  Patient problems: Perforation of Vessels

  MAUDE report 23334268 ↗
• InjurySep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AORTIC ARCH ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF), AND GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG), AND THE NON-GORE STENT GRAFTS. WHEN THE DSF WAS INSERTED VIA THE RIGHT FEMORAL ARTERY, RESISTANCE WAS ENCOUNTERED AT A STENOTIC SEGMENT OF THE RIGHT EXTERNAL ILIAC ARTERY. AFTER DEPLOYMENT OF THE NON-GORE STENT GRAFT (ZENITH), WHILE DELIVERING THE CTAG, THE ZENITH MIGRATED. A TOUCH-UP OF THE ZENITH WAS PERFORMED, AND THE CTAG WAS SUCCESSFULLY DEPLOYED. AFTER ALL STENT GRAFTS WERE DEPLOYED, A RETROGRADE DISSECTION WAS OBSERVED FROM THE RIGHT EXTERNAL ILIAC ARTERY TO THE RIGHT COMMON ILIAC ARTERY. A NON-GORE STENT (MISAGO) WAS PLACED AT THE DISSECTION SITE, AND THE DISAPPEARANCE OF THE FALSE LUMEN WAS CONFIRMED. PHYSICIAN¿S COMMENT THE AREA WAS CALCIFIED, AND PART OF THE LUMEN MEASURED APPROXIMATELY 6 MM, WHICH RAISED CONCERNS ABOUT ACCESS.

  Patient problems: Vascular Dissection

  MAUDE report 23012475 ↗
• InjurySep 7, 2025Difficult to Advance; Patient Device Interaction Problem; Difficult to Advance; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR TYPE A AORTIC DISSECTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH). DURING INSERTION OF 24 FR DSF SHEATH, RESISTANCE WAS FELT BUT IT WAS SUCCESSFULLY ADVANCED TO THE TARGET SITE. TWO CTAG ACS WERE IMPLANTED. WHEN BALLOONING FOR THE DISTAL CTAG AC WAS PERFORMED, THE DEVICE MOVED PROXIMALLY SLIGHTLY, RESULTING IN TYPE IB ENDOLEAK. THEREFORE, A DISTAL EXTENSION OF ZENITH TX2 WAS ADDITIONALLY PLACED DISTAL TO THE CTAG AC. THE TYPE IB ENDOLEAK WAS CLEARLY REDUCED BUT REMAINED. IT WAS LEFT FOR MONITORING. WHEN WITHDRAWING THE DSF SHEATH, THE RIGHT EXTERNAL ILIAC ARTERY WAS INJURED. DIAMETER OF THE INJURED SITE WAS UNKNOWN AS THERE WERE NO CT DATA AROUND THE INJURED SITE. TWO ADDITIONAL STENT GRAFTS WERE PLACED IN THE RIGHT EXTERNAL ILIAC ARTERY. ALSO, THE PUNCTURE SITE WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: ACCESS VESSEL TRAUMA WAS WITHIN EXPECTATION.

  Patient problems: Perforation of Vessels

  MAUDE report 22989595 ↗

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.