GORE DRYSEAL FLEX Introducer Sheath DSF2465Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132628407), received between Dec 3, 2018 and Aug 7, 2026 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryApr 22, 2026Patient Device Interaction Problem

  ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ARCH AORTA ANEURYSM. A GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF SHEATH) WAS USED FOR ACCESS. AN ATTEMPT WAS MADE TO INTRODUCE A 26FR DSF SHEATH; HOWEVER, IT COULD NOT BE ADVANCED AND WAS THEREFORE WITHDRAWN. THE PROCEDURE WAS SUBSEQUENTLY CONTINUED USING A 24FR DSF SHEATH. A VESSEL RUPTURE OF THE LEFT EXTERNAL ILIAC ARTERY WAS OBSERVED ON ACCESS CONFIRMATION ANGIOGRAPHY. THE VESSEL INJURY WAS TREATED SURGICALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 24949064 ↗
• InjuryMar 31, 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 TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, ALONG WITH THE GORE DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. FOLLOWING THE RIGHT-TO-LEFT AXILLARY ARTERY BYPASS, INSERTION OF A 24 FR SHEATH VIA THE RIGHT FEMORAL ARTERY WAS ATTEMPTED; HOWEVER, ADVANCEMENT BEYOND THE STENOTIC SEGMENT WAS UNSUCCESSFUL, AND THE APPROACH WAS ABANDONED. A CUTDOWN OF THE RIGHT EXTERNAL ILIAC ARTERY WAS THEN PERFORMED, AND THE SHEATH WAS REINSERTED. ALTHOUGH SIGNIFICANT RESISTANCE WAS ENCOUNTERED, SUCCESSFUL ADVANCEMENT WAS ACHIEVED. SUBSEQUENTLY, ANGIOGRAPHY OF THE ACCESS VESSEL REVEALED A DISSECTION OF THE RIGHT EXTERNAL ILIAC ARTERY; HOWEVER, BECAUSE NO BLEEDING WAS OBSERVED, THE PROCEDURE WAS COMPLETED WITH FOLLOW-UP OBSERVATION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 24738259 ↗
• MalfunctionOct 15, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  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 INSERTION OF THE AORTIC COMPONENT INTO THE SHEATH, A TRANSVERSE (SHORT-AXIS) TEAR WAS OBSERVED ON THE SHEATH AFTER SOME TIME. BLOOD LEAKAGE WAS NOTED FROM THE TEAR SITE; THEREFORE, THE PHYSICIAN SEALED THE TEAR SITE USING STERILE OPE TAPE, WHICH SUCCESSFULLY CONTROLLED THE LEAKAGE. THE SAME SHEATH WAS USED TO CONTINUE THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION. NO BLOOD TRANSFUSION WAS REQUIRED. ALTHOUGH STRONG RESISTANCE WAS REPORTEDLY ENCOUNTERED DURING DEVICE INSERTION, THERE WAS NO NOTICEABLE CATCHING OR SNAGGING AT THE TEAR SITE OF THE SHEATH. THE TEAR SITE OF THE SHEATH WAS LOCATED ON THE DISTAL PORTION OUTSIDE THE PATIENT¿S BODY. IT WAS REPORTED THAT THE TEAR SITE WAS LOCATED AT THE POINT OF THE MAXIMUM BEND FORMED WHEN HOLDING THE SHEATH AND/OR GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23287243 ↗
• InjuryAug 8, 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 THORACIC AORTIC ANEURYSM USING THE GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF). A CUTDOWN OF THE RIGHT COMMON FEMORAL ARTERY WAS PERFORMED, AND A 24FR DSF WAS INSERTED. DURING INSERTION, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, AND THE DSF BECAME STUCK MIDWAY. SUSPECTED DAMAGE TO THE RIGHT EXTERNAL ILIAC ARTERY LED TO THE PLACEMENT OF A STENT GRAFT AT THE DAMAGED SITE AND SURGICAL REPAIR. AS CONTINUATION OF THE PROCEDURE VIA CONTRALATERAL ACCESS WAS DEEMED DIFFICULT, THE PROCEDURE WAS DISCONTINUED AND RESCHEDULED FOR A LATER DATE.

  Patient problems: Perforation of Vessels

  MAUDE report 22746889 ↗
• InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING A GORE DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. AFTER DEPLOYING STENT GRAFTS THROUGH A 24FR SHEATH, ACCESS ANGIOGRAPHY REVEALED BLEEDING IN THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN ADVANCED THE SHEATH TO BLOCK BLOOD FLOW, AND A GORE VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS DEPLOYED IN THE RIGHT EXTERNAL ILIAC AS A TREATMENT. SUBSEQUENTLY, BLEEDING WAS OBSERVED NEAR THE PUNCTURE SITE OF THE RIGHT FEMORAL ARTERY VIA ANGIOGRAPHY. THE DISTAL PORTION OF THE RIGHT EXTERNAL ILIAC WAS LIGATED SURGICALLY. DURING BALLOON INFLATION IN THE RIGHT EXTERNAL ILIAC, BLEEDING FROM THE RIGHT COMMON ILIAC ARTERY WAS OBSERVED VIA ANGIOGRAPHY. THE RIGHT INTERNAL ILIAC WAS COIL EMBOLIZED, AND AN ILIAC EXTENDER WAS ADDITIONALLY DEPLOYED FROM THE RIGHT COMMON ILIAC TO THE EXTERNAL ILIAC. IT HAS BEEN REPORTED THAT THE BLEEDING FROM THE RIGHT COMMON ILIAC LIKELY OCCURRED DURING THE PLACEMENT OF THE VBX. FOLLOWING THIS, A GORE PROPATEN VASCULAR GRAFT (PROPATEN) WAS ANASTOMOSED TO THE RIGHT FEMORAL. THE DISTAL END OF THE VBX WAS THEN CUT

  Patient problems: Perforation of Vessels

  MAUDE report 22517062 ↗
• InjuryJun 23, 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 ENDOVASCULAR TREATMENT FOR A THORACIC AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. THE GORE® DRYSEAL FLEX INTRODUCER SHEATH AND THE GORE® TRI-LOBE BALLOON CATHETER WERE ALSO USED AS ACCESSORIES. AFTER THE DEPLOYMENT OF ALL STENT GRAFTS, A DOPPLER EXAMINATION REVEALED DIMINISHED PULSES IN THE RIGHT LEG. ANGIOGRAPHY CONFIRMED POOR BLOOD FLOW IN THE ARTERIES BELOW THE KNEE. THROMBECTOMY WAS PERFORMED AS A TREATMENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN¿S COMMENT: ¿THE PATIENT POSSIBLY HAD NARROW VESSELS. THE THROMBUS MIGHT HAVE DISLODGED WHILE MANIPULATING ANY DEVICES.¿

  Patient problems: Embolism/Embolus

  MAUDE report 22309250 ↗
• InjuryApr 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A THORACIC ANEURYSM USING GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. ACCESS ANGIOGRAPHY AFTER STENT GRAFT PLACEMENT REVEALED A VESSEL RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY CAUSED BY THE 24FR SHEATH. AS TREATMENT, THREE STENT GRAFTS WERE IMPLANTED FROM THE ORIGIN OF THE RIGHT COMMON ILIAC ARTERY TO THE LEVEL OF THE RIGHT FEMORAL HEAD. THE PUNCTURE SITE WAS SURGICALLY REPAIRED AS HEMOSTASIS COULD NOT BE ACHIEVED WITH THE PERCLOSE CLOSURE SYSTEM. THE ACCESS VESSEL REPORTEDLY MEASURED APPROXIMATELY 6.0 MM IN DIAMETER AT ITS NARROWEST SITE. THE PHYSICIAN WAS AWARE OF THE RISK OF ACCESS VESSEL INJURY.

  Patient problems: Perforation of Vessels

  MAUDE report 21916026 ↗
• InjuryMay 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR THORACIC (ARCH) AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM, NAJUTA THORACIC STENT GRAFT SYSTEM AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. ALL THE PLANNED DEVICES WERE IMPLANTED SUCCESSFULLY. AN ANGIOGRAPHY FOR THE ACCESS SITE SHOWED VASCULAR INJURY IN THE RIGHT EXTERNAL ILIAC ARTERY. A GORE® VIABAHN® ENDOPROSTHESIS WAS ADDITIONALLY IMPLANTED IN THE INJURED SITE. THE PATIENT TOLERATED THE PROCEDURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: ORIGINALLY, INSERTION OF A 24 FR SHEATH WAS EXPECTED TO BE DIFFICULT (VESSEL INNER DIAMETER WAS APPROXIMATELY 8 MM AND SMALLER THAN THE SHEATH OUTER DIAMETER 8.8 MM), SO VASCULAR INJURY WAS ALSO WITHIN EXPECTATION.

  Patient problems: Perforation of Vessels

  MAUDE report 19357014 ↗
• InjuryJul 27, 2023Malposition of Device; Patient Device Interaction Problem; Malposition of Device; Patient Device Interaction Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2023, THIS PATIENT UNDERWENT ANOTHER ENDOVASCULAR TREATMENT FOR A THORACIC DESCENDING AORTIC ANEURYSM USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC) AND GORE® DRYSEAL FLEX INTRODUCER SHEATH. TWO CTAG ACS WERE PLACED AS PLANNED. THEN, AN ACCESS SITE ANGIOGRAPHY SHOWED A VESSEL INJURY IN THE RIGHT EXTERNAL ILIAC ARTERY (EIA). FOR TREATMENT, AN ILIAC EXTENDER COMPONENT (PLL161007J) OF EXCLUDER WAS ADDITIONALLY PLACED. THIS COVERED THE RIGHT INTERNAL ILIAC ARTERY AND IT WAS AN UNPLANNED COVERAGE OF THE VESSEL. STILL, THERE WAS LEAKAGE AT THE INJURED SITE; THEREFORE, ANOTHER ILIAC EXTENDER (PLL161207J) WAS ADDED DISTAL TO THE PLL161007J. THERE WAS A MINOR ENDOLEAK, SO BALLOONING WAS PERFORMED. THE ENDOLEAK ALMOST DISAPPEARED, BUT THERE WAS A TYPE IIIA ENDOLEAK BETWEEN THE PLL161007J WHICH WAS IMPLANTED THIS TIME AND PLC161000J WHICH HAD BEEN IMPLANTED ON (B)(6), 2015; THEREFORE, ADDITIONAL CONTRALATERAL LEG (PLC181000J) WAS IMPLANTED. THE TYPE IIIA ENDOLEAK DISAP

  Patient problems: Obstruction/Occlusion

  MAUDE report 17404665 ↗
• InjuryApr 12, 2023Difficult to Advance; Difficult to Advance

  THE FOLLOWING DETAILS WERE REPORTED TO GORE: ON (B)(6) 2023, DURING AN ATTEMPTED TBE PROCEDURE FOR TREATMENT OF A ZONE 2 THORACIC AORTIC ANEURYSM, THE PHYSICIAN ATTEMPTED TO ADVANCE A 24 FR DRYSEAL FLEX INTRODUCER SHEATH INTO AN ILIAC CONDUIT SYSTEM HE HAD ALREADY PRE-TREATED WITH 10MM GORE® VIABAHN® ENDOPROSTHESES AND BALLOONED THE ACCESS. IT WAS REPORTED THAT APPROXIMATELY 95% OF THE ILIAC PATH HAD BEEN TREATED FOR THE EXPRESS PURPOSE OF CREATING A CONDUIT TO ACCOMMODATE A 24FR SHEATH. THE PHYSICIAN ADVANCED THE SHEATH UP THROUGH THE PATH OF VIABAHN®¿S THAT MADE UP THE ILIAC SYSTEM; HOWEVER AT THE ORIGIN OF THE COMMON FEMORAL ARTERY THAT WAS UNTREATED, THE DRYSEAL BECAME STUCK AND RESULTED IN A DISSECTION OF THE COMMON FEMORAL ARTERY ABOUT 5MM ABOVE THE LAST VIABAHN® DEVICE. THE PATIENT RECEIVED A TRANSFUSION OF APPROXIMATELY 3 UNITS OF BLOOD AND THE DISSECTED AREA WAS TRANSECTED. THE PROCEDURE WAS CONCLUDED AFTER TREATMENT OF THE DISSECTION. THE PATIENT TOLERATED THE PROCEDURE. THE COMMON FEMORAL ARTERY AT THE LOCATION OF THE DISSECTION WAS REPORTED TO HAVE BEEN MORE DISEASED THAN EXPECTED AND IS THOUGHT TO HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: Aneurysm

  MAUDE report 16728702 ↗
• InjuryFeb 3, 2021Human-Device Interface Problem; Break; Human-Device Interface Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND IT WAS PLANNED TO UTILIZE A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM TO TREAT A THORACIC AORTIC ANEURYSM. THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT TGMR404020E COMPONENT WAS ADVANCED TO THE INTENDED LOCATION IN THE DESCENDING AORTA WITH THE PHYSICIAN ACTUATING FIRST STAGE DEPLOYMENT. AFTER HAVING DEPLOYED THE STENT FOR ABOUT 3 CM, THE DEPLOYMENT LINE SUDDENLY BROKE WITHOUT PRIOR RESISTANCE FELT WHEN PULLING THE LINE. THE PHYSICIAN REVERTED TO THE BACKUP DEPLOYMENT MECHANISM BUT THE FIBER IN THE ACCORDING CHANNEL WAS NO LONGER PRESENT. AS DISTAL BLOOD FLOW WAS NOW IMPEDED DUE THE DEVICE STILL BEING CLOSED TOWARDS DISTAL, THERE WAS A NEED TO SOLVE THE SITUATION SOMEWHAT QUICKLY. THEREFORE, THE PHYSICIAN DECIDED TO USE A GORE® DRY SEAL FLEX INTRODUCER SHEATH DSF (24/65) AND PULLED THE DEVICE IN ITS CURRENT STATE OF DEPLOYMENT BACK INTO THE SHEATH WITH FORCE. WHEN RAPIDLY RETRACTING THE SHEATH OUT OF THE PATIENT THE COMMON ILIAC ARTERY WAS INJURED AT THE POINT OF ACCESS WHICH SUBSEQUENTLY WAS PATCHED. THE PROCEDURE THEN PROCEEDED AND A BOLTON THORACIC STENT GRAFT WAS IMPLANTED. THE

  Patient problems: Intimal Dissection; Perforation of Vessels

  MAUDE report 11276808 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF A DESCENDING AORTIC ANEURYSM USING CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES. THE DEVICES WERE IMPLANTED SUCCESSFULLY AT THE INTENDED POSITION. AN ANGIOGRAPHY IDENTIFIED AN ENDOLEAK OF UNKNOWN TYPE (POSSIBLY PROXIMAL TYPE I OR TYPE II), PERTAINING TO THE (B)(4). THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK, AND CONCLUDE THE PROCEDURE. AFTER REMOVAL OF A GORE® DRYSEAL FLEX INTRODUCER SHEATH, THE ACCESS RUPTURE WAS IDENTIFIED AT THE RIGHT COMMON ILIAC ARTERIES. THE RUPTURE WAS REPAIRED BY IMPLANTING A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT THE ACCESS VESSEL WAS TORTUOUS, AND THERE WAS DIFFICULTY ADVANCING THE DSF2465. NO FURTHER ISSUES WERE OBSERVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8671057 ↗
• InjuryDec 3, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THE PATIENT UNDERWENT AN INTERVENTION TO TREAT A DISTAL TYPE I ENDOLEAK ORIGINATING FROM A PREVIOUSLY IMPLANTED TX2 STENT GRAFT WITH A CONFORMABLE GORE TAG® THORACIC ENDOPROSTHESIS USING GORE® DRYSEAL FLEX INTRODUCER SHEATH. AN ACCESS WAS MADE FROM THE LEFT FEMORAL ARTERY. A DSF2465 WAS INSERTED INTO THE ACCESS VESSEL, BUT THERE WAS RESISTANCE DUE TO ACCESS VESSEL TORTUOUS, AND IT WAS UNABLE TO ADVANCE THE DSF2465 ABOVE THE LEFT EXTERNAL ILIAC ARTERY. THE DSF2465 WAS REMOVED FROM THE PATIENT, AND ANOTHER ATTEMPT WAS MADE WITH A DFS2433, BUT THE DFS2433 ALSO WAS NOT ABLE TO BE ADVANCED ABOVE THE LEFT EXTERNAL ILIAC ARTERY. THE LEFT ACCESS VESSEL WAS DILATED WITH A PTA BALLOON, AND AN ATTEMPT WAS MADE AGAIN WITH THE DFS2433, BUT THE ATTEMPT WAS ALSO UNSUCCESSFUL. THE PHYSICIAN ONLY ADVANCED A DILATOR INTO THE ACCESS VESSEL, AND CONFIRMED THAT THE DILATOR PASSED THE LEFT EXTERNAL ILIAC ARTERY. THEN THE PHYSICIAN ADVANCED AGAIN THE DFS2433 ONLY TO THE LEFT EXTERNAL ILIAC ARTERY AND ADVANCED THE DELIVERY CATHETER OF A TGU454520J WITHOUT THE SHEATH ABOVE THE LEFT EXTERNAL ILIAC ARTERY. THE ENDOPROSTHESIS WAS SUCCESSFULLY IMPLANTED. AFTER THE SHEATH WAS REMOVED FROM THE PA

  Patient problems: Aneurysm

  MAUDE report 8127451 ↗

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.