GORE DRYSEAL FLEX Introducer SheathRecalls & reported problems across all models

We found 29 models of GORE DRYSEAL FLEX Introducer Sheath by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 1,009 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2018 and Sep 30, 2026 — classified as 34 deaths, 898 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (348 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE DRYSEAL FLEX Introducer Sheath problems

GORE DRYSEAL FLEX Introducer Sheath models

29 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE DRYSEAL FLEX Introducer Sheath DSF2233

  INTRODUCER, CATHETER
  8 deaths297 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF2433

  INTRODUCER, CATHETER
  7 deaths152 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1633

  INTRODUCER, CATHETER
  3 deaths135 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1233

  INTRODUCER, CATHETER
  1 death92 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1833

  INTRODUCER, CATHETER
  4 deaths86 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF2033

  INTRODUCER, CATHETER
  1 death77 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1245

  INTRODUCER, CATHETER
  2 deaths36 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1433

  INTRODUCER, CATHETER
  3 deaths34 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF2265

  INTRODUCER, CATHETER
  1 death27 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF2465

  INTRODUCER, CATHETER
  14 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF2633

  INTRODUCER, CATHETER
  1 death10 reports
• GORE® DrySeal Flex Introducer Sheath GDSF2233

  Introducer, catheter
  7 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1865

  INTRODUCER, CATHETER
  6 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF2065

  INTRODUCER, CATHETER
  1 death6 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF2665

  INTRODUCER, CATHETER
  4 reports
• GORE® DrySeal Flex Introducer Sheath GDSF1233

  Introducer, catheter
  1 death4 reports
• GORE® DrySeal Flex Introducer Sheath GDSF1833

  Introducer, catheter
  4 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1065

  INTRODUCER, CATHETER
  3 reports
• GORE® DrySeal Flex Introducer Sheath GDSF2433

  Introducer, catheter
  3 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1465

  INTRODUCER, CATHETER
  1 death2 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1665

  INTRODUCER, CATHETER
  2 reports
• GORE DRYSEAL FLEX Introducer Sheath DSF1045

  INTRODUCER, CATHETER
  1 report
• GORE DRYSEAL FLEX Introducer Sheath DSF1265

  INTRODUCER, CATHETER
  1 report
• GORE® DrySeal Flex Introducer Sheath GDSF1245

  Introducer, catheter
  1 report
• GORE® DrySeal Flex Introducer Sheath GDSF1265

  Introducer, catheter
  1 report
• GORE® DrySeal Flex Introducer Sheath GDSF1465

  Introducer, catheter
  1 report
• GORE® DrySeal Flex Introducer Sheath GDSF1633

  Introducer, catheter
  1 report
• GORE® DrySeal Flex Introducer Sheath GDSF2265

  Introducer, catheter
  1 report
• GORE® DrySeal Flex Introducer Sheath GDSF2465

  Introducer, catheter
  1 report

Recent GORE DRYSEAL FLEX Introducer Sheath adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50950508 ↗
• 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 30, 2026Patient Device Interaction Problem

  Patient problems: Perforation of Vessels

  MAUDE report 50941531 ↗
• 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, 2026Adverse Event Without Identified Device or Use 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 imp

  Patient problems: Embolism/Embolus; Ischemia

  MAUDE report 50911724 ↗
• 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 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 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  The following was reported to Gore from the iMedidata database: On (b)(6) 2026, the patient underwent endovascular treatment for an aortoiliac aneurysm. The patient was treated with GORE®¿EXCLUDER®¿Conformable AAA Endoprosthesis, GORE® EXCLUDER® AAA Endoprosthesis devices and GORE®¿EXCLUDER®¿Iliac Branch Endoprosthesis devices. The GORE® devices were successfully navigated to the intended location and successfully deployed. On (b)(6) 2026, the patient developed an infected inguinal pseudoaneurysm. A percutaneous transluminal angioplasty was performed to treat it.On (b)(6) 2026, the infected inguinal pseudoaneurysm was recovered / resolved with sequelae.

  Patient problems: Pseudoaneurysm; Unspecified Infection

  MAUDE report 50878505 ↗
• 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 31, 2026Adverse Event Without Identified Device or Use Problem

  The following information was reported to Gore:On (b)(6), 2026, angiography revealed that the right internal iliac artery was patent.On (b)(4), 2026, a patient underwent an endovascular procedure to treat an abdominal aortic aneurysm and common iliac artery aneurysms using GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) devices and GORE® DrySeal Flex Introducer Sheath (DSF) devices.Two DSFs were inserted into both femoral arteries, and a pull-through wire was created. The iliac branch component was deployed in the left common iliac artery via a DSF inserted through the right femoral artery, while the internal iliac component was deployed in the left internal iliac artery via a DSF inserted through the left femoral artery.Another iliac branch component was deployed in the right common iliac artery via a DSF inserted through the right femoral artery. After that, angiography revealed that the right internal iliac artery was occluded. The timing of the occlusion was unknown. The iliac branch component did not occlude the right internal iliac artery physically.The right internal iliac artery could not be cannulated due to the occlusion; therefore, the internal iliac gate of the iliac

  Patient problems: Obstruction/Occlusion

  MAUDE report 50515409 ↗
• InjuryAug 10, 2026Patient Device Interaction Problem

  The following information was reported to Gore:(b)(6), 2026, this patient underwent an endovascular treatment for abdominal aortic aneurysm using GORE® EXCLUDER® AAA Endoprosthesis and GORE® DrySeal Flex Introducer Sheath.A 16 Fr Sheath was smoothly inserted from the right femoral artery and all the planned devices were implanted successfully. The final angiography showed a vascular dissection on the right external iliac artery. A bare-metal stent was additionally implanted at the dissected site. The patient tolerated the procedure. The reporting physician commented as follows: There was no resistance during advancement of the sheath, so the cause of dissection was unclear.

  Patient problems: Vascular Dissection

  MAUDE report 50189511 ↗
• 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 ↗
• InjuryAug 7, 2026Material Separation

  The following was reported to Gore:On (b)(6), 2026, the patient underwent endovascular reintervention for a type IA endoleak ((b)(4)). An 18 Fr GORE® DrySeal Flex Introducer Sheath was used during the procedure.It was reported that the patient had undergone multiple prior open groin procedures and had significant scar tissue within the tissue tracts. Placement of the sheath was initially attempted through the right femoral access but was unsuccessful due to resistance. The sheath was subsequently inserted through the left femoral access with significant force.The treatment devices were delivered successfully. However, it was reported that during removal of the sheath over a Lunderquist guidewire, significant resistance was encountered at the arteriotomy, and substantial force was required. The sheath reportedly began to accordion and stretch, and its coil reinforcement became exposed and was visible around the guidewire. After removal of the sheath and guidewire, fluoroscopy showed that the radiopaque marker from the distal end of the sheath remained in the patient.The physician performed a common femoral artery cutdown because the marker was suspected to be extravascular within th

  Patient problems: Foreign Body In Patient

  MAUDE report 50175189 ↗
• InjuryAug 7, 2026Patient Device Interaction Problem

  On (b)(6) 2026, the patient underwent endovascular treatment for an aortic arch aneurysm. A GORE® DrySeal Flex Introducer Sheath (DSF sheath) was used for access. Reportedly, during insertion of the 24Fr DSF sheath, resistance was felt, but the procedure was continued. After all stent grafts were placed, access confirmation angiography was performed, and a rupture in the right external iliac artery was observed. Due to a decrease in blood pressure, intra-operative transfusion of blood products was required. Additional four stent grafts were placed to treat the vessel rupture. The patient tolerated the procedure.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 50169783 ↗
• InjuryAug 6, 2026Patient Device Interaction Problem

  The following information was reported to Gore:On (b)(6) 2026, a patient underwent a total arch replacement with the elephant trunk technique to treat a thoracic aortic aneurysm.On (b)(6) 2026, the patient underwent endovascular treatment using GORE® DRYSEAL Flex Introducer Sheath and GORE TAG Conformable Thoracic Stent Grafts with ACTIVE CONTROL System (CTAGAC) devices. The devices were deployed continuously with the elephant trunk.The sheath and CTAGAC were difficult to advance into the elephant trunk due to the steepness of the arch. The physician attempted to hold the sheath under the elephant trunk and to advance the CTAGAC when a dissection formed in the descending aorta associated with the tip of the sheath.The primary entry was closed with the CTAGAC. The false lumen flow was resolved. However, re-entry was still observed in the ventral branch. No special treatment was performed for re-entry.The patient tolerated the procedure.

  Patient problems: Vascular Dissection

  MAUDE report 50151330 ↗

Other W. L. Gore & Associates, Inc. products

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports
• GORE TAG Conformable Thoracic Stent Graft25 models · 325 reports