GORE DRYSEAL FLEX Introducer Sheath DSF2633Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132630103), received between Nov 27, 2018 and Feb 5, 2026 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Patient Device Interaction Problem

  ON (B)(6) 2020, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ARCH AORTA ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC ENDOPROSTHESIS. ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DEVICE MIGRATED DISTALLY. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. AFTER ADDITIONAL STENT GRAFTS WERE PLACED PROXIMALLY, THE LEFT EXTERNAL ILIAC ARTERY RUPTURE WAS OBSERVED ON THE ACCESS ANGIOGRAPHY. TWO STENT GRAFTS WERE PLACED TO TREAT THE RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE DIAMETER OF THE RUPTURED AREA WAS APPROXIMATELY 7.5 ~ 7.9MM.

  Patient problems: Perforation of Vessels

  MAUDE report 24265475 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE PIVOTAL STUDY FOR THE GORE® ASCENDING STENT GRAFT IN THE TREATMENT OF LESIONS OF THE ASCENDING AORTA (ASG DEVICE): ON (B)(6) 2025 , THE PATIENT WAS IMPLANTED WITH GORE® ASG DEVICE AND A GORE® DRYSEAL SHEATH WAS USED DURING THE PROCEDURE. THE PATIENT WAS BEING TREATED FOR A THORACIC ANEURYSM. FOLLOWING VASCULAR ACCESS AND DURING THE PROCEDURE, A PERFORATION OF THE LEFT COMMON ILIAC ARTERY WAS IDENTIFIED. A GORE® VIABAHN DEVICE WAS DEPLOYED ACROSS THE SITE OF PERFORATION WITH SATISFACTORY APPOSITION AND SEALING CONFIRMED ANGIOGRAPHICALLY. SUBSEQUENT IMAGING REVEALED A DISSECTION AND OCCLUSION INVOLVING THE LEFT COMMON FEMORAL ARTERY. THIS WAS MANAGED WITH ENDOVASCULAR PLACEMENT OF AN ADDITIONAL GORE® VIABAHN DEVICE ACROSS THE DISEASED SEGMENT. RESTORATION OF FLOW WAS CONFIRMED WITH COMPLETION ANGIOGRAPHY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 22484388 ↗
• InjuryDec 19, 2023Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Insufficient Device Problem Information

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACIC AORTIC ANEURYSM. FOR ACCESS, A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED. AS REPORTED, NO RESISTANCE WAS FELT WHEN INSERTING AND WITHDRAWING THE SHEATH. IT WAS REPORTED THERE WERE NO CONCERNS WITH PATIENT'S ANATOMY, AND NO PRE-EXISTING DEVICE(S) THAT COULD HAVE INTERFERED WITH ADVANCEMENT OF THE DEVICES. DURING THE PROCEDURE, AFTER THE SHEATH WAS USED TO INSERT THE GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS, THE RIGHT EXTERNAL ILIAC ARTERY WAS RUPTURED. REPORTEDLY, THE RIGHT EXTERNAL ILIAC ARTERY WAS 9MM. THE DAMAGED VESSEL WAS COVERED WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS REPORTED THAT AFTER 24 HOURS THE VIABAHN DEVICE OCCLUDED. NO INTERVENTION WAS PERFORMED. AS REPORTED, THE PHYSICIAN STATED LACK OF VESSEL ELASTICITY AND TORTUOSITY MAY HAVE LED TO THE VESSEL DAMAGE DURING IMPLANT. THE PHYSICIAN DID NOT SPECULATE ON WHY THE VIABAHN DEVICE OCCLUDED. THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 18361017 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM, ZONE 0/1, USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. ON (B)(6) 2023, THE PATIENT ATTENDED THE OUTPATIENT CLINIC FOR A ONE-MONTH FOLLOW-UP, PRESENTING WITH TENDERNESS AROUND THE RIGHT INGUINAL WOUND AND EXHIBITING SWELLING AND REDNESS. ELEVATED INFLAMMATORY RESPONSE WAS NOTED IN THE BLOOD EXAMINATION, AND CT REVEALED ABSCESS FORMATION ON THE VENTRAL SIDE OF THE RIGHT FEMORAL ARTERY. CONSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR SURGICAL DRAINAGE, WHICH RESULTED IN THE DISCHARGE OF A SUBSTANTIAL AMOUNT OF PUS. INTRAVENOUS INFUSION OF CEFAZOLIN SODIUM ANTIBIOTICS WAS INITIATED. ON (B)(6) 2023, VAC (VACUUM-ASSISTED CLOSURE) THERAPY WAS ADMINISTERED. PUS CULTURE RESULTS SHOWED THE PRESENCE OF GPC (GRAM-POSITIVE COCCI), LEADING TO THE ADDITION OF VANCOMYCIN HYDROCHLORIDE. ON (B)(6) 2023, PUS CULTURE IDENTIFIED THE GPC TO BE METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MMSA), AND VANCOMYCIN WAS SUBSEQUENTLY DISCONTINUED WHILE THE INFUSION OF CEFAZOLIN SODIUM WAS CONTINUED. GIVEN THAT THE ABSCESS WAS LOCATED IN THE DEVICE DELIVERY SITE (VENTRAL SIDE OF THE RIGHT FEMORAL ARTERY), THE ADVERSE

  Patient problems: Unspecified Infection

  MAUDE report 16594105 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE SSB11-02 PIVOTAL CLINICAL STUDY. ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM, ZONE 0/1, USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. A LOCALIZED DISSECTION AT THE RIGHT EXTERNAL ILIAC ARTERY WAS IDENTIFIED AFTER REMOVAL OF THE SHEATH FROM THE RIGHT FEMORAL ARTERY. FOR TREATMENT, AN ADDITIONAL STENT GRAFT (GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS) WAS IMPLANTED AND THE DISSECTION SITE WAS REPAIRED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 16416983 ↗
• InjuryMar 4, 2022Difficult to Remove; Difficult to Remove

  ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A PSEUDOANEURYSM IN THE ZONE TWO USING GORE® TAG® THORACIC BRANCH ENDOPROSTHESES. A GORE® DRYSEAL SHEATH WAS USED FOR ACCESS. REPORTEDLY, THE PROCEDURE WAS DONE ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). PERCUTANEOUS THE RIGHT SIDED ACCESS WAS GAINED, SHEATHS UP SIZED TO DSF2633, AND HEMOSTASIS WAS ACHIEVED AS PER NORMAL OPERATING PROCEDURES. THE PATIENT WAS SUCCESSFULLY TREATED WITH A TAC084015C AND A TSB081506C WITHOUT ANY COMPLICATIONS. IT WAS REPORTED, THAT AT THE END OF THE CASE, DURING REMOVAL OF THE SHEATH AND VESSEL CLOSURE, RESISTANCE WAS FELT ON WITHDRAWAL. UNDER FLUOROSCOPY, IT WAS NOTICED THERE WAS TORTUOSITY AND A KINK IN THE EXTERNAL ILIAC ARTERY. THE SHEATH WAS PULLED BACK, AND A BLUSH WAS NOTICED. A RUPTURE WAS INDICATING. A GORE® VIABAHN® ENDOPROSTHESIS WAS DEPLOYED AND EXCLUDED THE RUPTURE WITHIN 4-5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IN DISCUSSION WITH THE PHYSICIAN, THERE WAS ONLY NOTICED MINIMAL BLOOD LOSS (LESS THAN A LITER) AND EXTENDED OR TIME. THE MDS STATED THERE WAS NO SITE COMPLICATIONS OR HEMATOMA AT THE GROIN. NO OTHER COMPLICATIONS. THE PATIENT AWAKE AND WAS EATING

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pseudoaneurysm

  MAUDE report 13673797 ↗
• InjuryFeb 17, 2022Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Improper or Incorrect Procedure or Method; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE (B)(6) CLINICAL STUDY. ON (B)(6) 2022, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ARCH ANEURYSM (ZONE 0/1) USING A 26FR GORE® DRYSEAL FLEX INTRODUCER SHEATH. DURING THE PROCEDURE, BLEEDING FROM THE ACCESS VESSEL ON THE RIGHT SIDE AND A DECREASE IN BLOOD PRESSURE REPORTEDLY OCCURRED WHEN THE GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS REMOVED FROM THE PUNCTURE SITE. BLOOD LOSS MEASURED A REPORTED 2440ML. THE CAUSE OF THE RUPTURE/DISRUPTION OF THE ACCESS VESSEL WAS NOT INDICATED ALTHOUGH IT WAS REPORTED THE EVENT WAS RELATED TO THE ENDOVASCULAR PROCEDURE. THE RIGHT EXTERNAL ILIAC/FEMORAL ARTERY REGION MEASURED 8MM IN DIAMETER, AND IT WAS UNKNOWN IF THE PATIENT HAD ANY NOTABLE ANATOMIC ISSUES. ACCORDING TO THE REPORT, THE PATIENT¿S BLOOD PRESSURE RECOVERED AFTER INTRA-OPERATIVE TRANSFUSION OF RED CELL CONCENTRATE (8 UNITS) AND FRESH FROZEN PLASMA (8 UNITS). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 13548919 ↗
• DeathAug 11, 2021Adverse 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 A PATIENT WAS UNDERGOING TREATMENT OF AN ASCENDING AORTIC ANEURYSM AS A SUBJECT IN THE(B)(4) CLINICAL STUDY. THE PROCEDURE INCLUDED THE USE OF FOUR GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED FOR ACCESS. DURING THE PROCEDURE A SERIES OF ADVERSE EVENTS OCCURRED WHICH LED TO EVENTUAL INTRAPROCEDURAL DEATH. THE PHYSICIAN STATED THE FOLLOWING: ¿IN SUMMARY, I BELIEVE SHE SUFFERED A SERIES OF STRESSES THAT CUMULATIVELY RESULTED IN HER ARREST WHEN SHE BECAME HYPOXEMIC DURING THE REINTUBATION EVENT. THE SERIES OF STRESSED INCLUDED THE INTERMITTENT HYPOTENSION FROM THE WIRE, TREATED WITH PRESSORS FOR SEVERAL HOURS. HER LEFT PELVIS/LEG WERE ISCHEMIC FOR ABOUT 3.5 HOURS. THE DIFFICULTY ESTABLISHING DISTAL SEAL IN THE DTA, THE LEFT FEMORAL CUT-DOWN ALL CAUSED PROLONGATION OF THE OPERATION. SHE HAD AN ACUTE BLEED FROM THE ACCESS SITE COMPLICATION, WHICH ALTHOUGH IMMEDIATELY RECOGNIZED AND TREATED WAS YET ANOTHER HIT. AFTER ALL THESE EVENTS, I SUSPECT THAT HER HYPOXEMIA EXHAUSTED HER PHYSIOLOGIC RESERVE AND SHE CODED. THE DEVICE PERFORMED AS ANTICIPATED AND

  Patient problems: Vascular Dissection

  MAUDE report 12308912 ↗
• InjurySep 15, 2019Adverse 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), 2019, A PATIENT WAS TREATED WITH GORE INVESTIGATIONAL DEVICES FROM THE ARISE TBE 14-02 CLINICAL TRIAL, IN EMERGENT COMPASSIONATE USE. AS PART OF THE PROCEDURE, RIGHT FEMORAL ACCESS WAS OBTAINED USING A 26FR GORE® DRYSEAL FLEX SHEATH. THE SHEATH WAS PREPPED PER IFU. THE ACCESS VESSEL DIAMETER WAS 9MM. WHEN THE PROCEDURE WAS COMPLETED, THE SHEATH WAS REMOVED. A LARGE SEGMENT OF VESSEL ENDOTHELIUM AND PLAQUE WAS DISRUPTED, DESPITE THE SHEATH WAS PERIODICALLY ROTATED DURING THE PROCEDURE. THIS WAS TREATED BY MEANS OF ENDARTERECTOMY AND COMPLEX PRIMARY REPAIR AND RECONSTRUCTION OF THE FEMORAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE. NO TRANSFUSION WAS REQUIRED. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY 5.

  Patient problems: Perforation of Vessels

  MAUDE report 9060603 ↗
• InjuryNov 27, 2018Adverse 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) 2018, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT IN THE THORACIC AORTA, ZONE 0, WITH GORE® TAG® THORACIC BRANCH ENDOPROSTHESES AND A CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS AS DISTAL EXTENSION TO AORTIC COMPONENT. ACCORDING TO THE REPORT ALL DEVICES WERE POSITIONED AND IMPLANTED WITHOUT ISSUE. A GORE® DRYSEAL FLEX SHEATH WAS USED FOR ACCESS. DURING THE PROCEDURE AN ILIAC ARTERY RUPTURE OCCURRED. ESTIMATED BLOOD LOSS WAS 2500ML. BLOOD REPLACEMENT PRODUCTS WERE GIVEN AND A RIGHT FEMORAL ARTERY REPAIR WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. POST-OPERATIVELY THE PATIENT HAD LOW BLOOD PRESSURE, RESPIRATORY INSUFFICIENCY AND ATRIAL FIBRILLATION, WHICH WERE ALL MEDICALLY MANAGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8108813 ↗

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.