GORE EXCLUDER AAA Endoprosthesis PXC201200Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00733132610044), received between Jul 31, 2019 and Nov 12, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR BI-LATERAL COMMON AND INTERNAL ILIAC ARTERY ANEURYSMS, A DISTAL TYPE I ENDOLEAK AND ENLARGEMENT OF THE AAA. THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES (EXCLUDER), GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICES AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. THE RIGHT INTERNAL ILIAC ARTERY WAS COILED AND IT WAS ATTEMPTED TO IMPLANT IBE ON LEFT, HOWEVER THE PHYSICIAN WAS UNABLE TO GET WIRE FAR ENOUGH DOWN INTO LEFT INTERNAL ILIAC DUE TO THE PATIENT¿S TORTUOUS ANATOMY. WE ENDED UP COILING THE LEFT INTERNAL ILIAC AND COVERING INTO THE LEFT EXTERNAL ILIAC ARTERY. THE PHYSICIAN ALSO EXTENDED THE RIGHT LIMB OF GRAFT INTO THE RIGHT EXTERNAL ILIAC ARTERY.

  Patient problems: Aneurysm expansion

  MAUDE report 23538077 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. A TOTAL OF FOUR COMPONENTS WERE DEPLOYED: ONE TRUNK IPSILATERAL LEG AND THREE CONTRALATERAL LEGS. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED AS BOTH COMMON ILIAC ARTERIES HAD BECOME ANEURYSMAL. A TOTAL OF SEVEN NEW COMPONENTS WERE PLACED: ONE CONTRALATERAL LEG, TWO ILIAC BRANCH COMPONENTS, TWO INTERNAL ILIAC COMPONENTS, AND TWO VBX. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: Aneurysm expansion

  MAUDE report 23376899 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, THE RIGHT COMMON ILIAC ARTERY WAS FOUND TO HAVE BECOME ANEURYSMAL. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED, ADDITIONAL STENT GRAFTS WERE PLACED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 20792685 ↗
• InjuryJul 22, 2024Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A TRUNK IPSILATERAL LEG ENDOPROSTHESIS AND A CONTRALATERAL LEG WERE IMPLANTED. THE CONTRALATERAL LEG WAS IMPLANTED IN THE LEFT LIMB. ON (B)(6)2024, THE PATIENT CAME TO THE HOSPITAL COMPLAINING A STOMACHACHE. A CT REVEALED THE ABDOMINAL AORTIC ANEURYSM RUPTURE AND SUSPECTED A DISTAL TYPE I ENDOLEAK FROM THE RIGHT LEG, A DISTAL TYPE I ENDOLEAK FROM THE LEFT LEG, A PROXIMAL ENDOLEAK AND/OR A TYPE IIIA ENDOLEAK. REPORTEDLY, THE PATIENT VITAL SIGNS ARE STABLE. AN URGENT EVAR WAS PERFORMED TO TREAT THEM. A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED TO EXTEND THE RIGHT LEG BECAUSE THE DISTAL TYPE I ENDOLEAK FROM THE RIGHT LEG WAS SUSPECTED. IT WAS NOT CONFIRMED AN OBVIOUS ENDOLEAKS FROM THE PROXIMAL OF THE TRUNK AND THE DISTAL OF THE LEFT LEG. IT WAS OBSERVED THAT A GATE OF TRUNK IPSILATERAL LEG ENDOPROSTHESIS AND A CONTRALATERAL LEG ENDOPROSTHESIS ARE DISCONNECTED. THEREFORE, AN ADDITIONAL CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED TO RELINE THE GATE AND THE CONTRALATERAL LEG ENDOPROSTHESIS. AN ANGIOGRAPHY RE

  Patient problems: Aneurysm expansion; Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 19790468 ↗
• InjuryFeb 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2008, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESES. ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED TO TREAT A DISTAL TYPE I ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS IMPLANTED INTO THE RIGHT SIDE OF THE PATIENT AS A TREATMENT. AN AORTIC EXTENDER COMPONENT WAS ALSO IMPLANTED PROXIMALLY FOR A SUSPECTED PROXIMAL TYPE I ENDOLEAK. ON AN UNKNOWN DATE, EMBOLIZATION WITH NBCA WAS PERFORMED (DETAILS UNKNOWN). ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED TO TREAT A DISTAL TYPE I ENDOLEAK FROM THE LEFT COMMON ILIAC ARTERY USING GORE® EXCLUDER®AAA ENDOPROSTHESES. A CONTRALATERAL LEG COMPONENT WAS IMPLANTED INTO THE LEFT SIDE OF THE PATIENT AS A TREATMENT. TWO AORTIC EXTENDER COMPONENT WERE ALSO IMPLANTED PROXIMALLY FOR A SUSPECTED PROXIMAL TYPE I ENDOLEAK. ANEURYSM ENLARGEMENT WAS NOT REPORTED. ADDITIONAL DETAILS OF THE 2008 AND 2020 PROCEDURES WERE NOT ABLE TO BE OBTAINED.

  Patient problems: Clinical Endoleak

  MAUDE report 18655275 ↗
• InjuryApr 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE; ON (B)(6) 2016, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, CT REVEALED THAT THE RIGHT COMMON ILIAC ARTERY WAS DILATED. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AS PLANNED. ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES (TWO CONTRALATERAL LEG ENDOPROSTHESES) WERE IMPLANTED TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16688999 ↗
• InjuryFeb 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2012, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT A PROCEDURE TO TREAT A TYPE IB ENDOLEAK THAT OCCURRED WHEN THE RIGHT COMMON ILIAC HAD EXPERIENCED DILATATION. THE RIGHT INTERNAL ILIAC WAS COILED AND COVERED WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16443705 ↗
• InjuryJul 29, 2022No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2022, GRADUAL ENLARGEMENT OF THE ANEURYSM WAS OBSERVED. ABDOMINAL ULTRASONOGRAPHY REPORTEDLY REVEALED A PROXIMAL TYPE I ENDOLEAK. IT WAS SUGGESTED THAT TYPE I APPEARED BECAUSE THE SEAL ZONE BECAME SHORTER AS THE DIAMETER OF THE ANEURYSM ENLARGED. ON (B)(6) 2022, THE PATIENT UNDERWENT REINTERVENTION WHEREBY ADDITIONAL STENT GRAFTS WERE IMPLANTED TO EXTEND THE DEVICE SYSTEM PROXIMALLY, AND TO EXTEND THE BILATERAL LIMBS DISTALLY TO PREVENT FUTURE TYPE IB ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131274 ↗
• InjuryMay 15, 2022Adverse 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) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERIAL ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. DURING THE FOLLOW-UP PERIOD, NEW ANEURYSMS WERE FORMED IN THE LEFT COMMON ILIAC AND INTERNAL ILIAC ARTERIES. THEREFORE, AN ADDITIONAL PROCEDURE WAS INDICATED FOR A POSSIBLE TYPE IB ENDOLEAK. ON (B)(6) 2022, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE) WERE ADDITIONALLY IMPLANTED INTO THE LEFT ILIAC ARTERY. THE ILIAC BRANCH COMPONENT WAS DEPLOYED WITHOUT PROBLEMS. TWO INTERNAL ILIAC COMPONENTS WERE PLACED IN THE INTERNAL ILIAC ARTERY; HOWEVER, TYPE IB ENDOLEAK WAS FOUND AND THE INTERNAL ILIAC ARTERY WAS EMBOLIZED EVENTUALLY. DURING THE ADDITIONAL PROCEDURE, IT WAS FOUND THAT THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG WHICH IMPLANTED IN THE INITIAL PROCEDURE WAS A LITTLE BIT MIGRATED DISTALLY THOUGH NO TYPE IA ENDOLEAK WAS NOTED. THEREFORE, AN AORTIC EXTENDER WAS ALSO ADDITIONALLY IMPLANTED INTO THE AORTIC NECK TO PREVENT POTENTIAL TYPE IA ENDOLEAK. THE FINAL ANGIOGRAPHY SHOWED NO ENDOLEAK. THE PATIENT TOLERATED TH

  Patient problems: Aneurysm

  MAUDE report 14403805 ↗
• InjuryMay 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2012, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, ENLARGEMENT OF THE ANEURYSM AND BILATERAL COMMON ILIAC ARTERIES WAS OBSERVED, AND DISTAL TYPE I ENDOLEAK ON BOTH SIDES WAS SUSPECTED. ON (B)(6) 2022, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE WHEREBY ALL COMPONENTS WERE REMOVED, AND THE VASCULATURE WAS SURGICALLY REPAIRED. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL EVENT INFORMATION WAS REQUESTED, BUT NONE WAS PROVIDED.

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

  MAUDE report 14359364 ↗
• InjuryFeb 23, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES (PXT261412 AND PXC201200). TWO ENDURANT LEGS WERE ADDITIONALLY IMPLANTED TO THE IPSILATERAL SIDE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO TREAT A TYPE IB ENDOLEAK OF THE IPSILATERAL ENDURANT LEGS. A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLC271200J) WAS ADDED IN THE IPSILATERAL SIDE. ON (B)(6) 2022, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE AS THE LEFT (IPSILATERAL) TYPE IB ENDOLEAK WAS CONFIRMED TO REMAIN. TWO CONTRALATERAL LEGS (PLC141400J AND PLC141200J) WERE IMPLANTED INTO THE LEFT SIDE AND THE TREATMENT AREA WAS EXTENDED TO THE EXTERNAL ILIAC ARTERY. ALSO, THE LEFT INTERNAL ILIAC ARTERY WAS COIL-EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. A MINOR TYPE IB ENDOLEAK OF THE CONTRALATERAL EXCLUDER LEG WAS ALSO FOUND, AND AN ADDITIONAL PROCEDURE WAS PLANNED FOR IT. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: DURING THE INITIAL PROCEDURE, THE IPSILATERAL LEG SEEMED TO BE UNDERSIZED BUT PRESERVING INTERNAL ILIAC ARTERY WAS PRIORITIZE

  Patient problems: Aneurysm

  MAUDE report 13583570 ↗
• InjuryDec 14, 2021Malposition of Device; Malposition of Device

  ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ACCORDING TO THE REPORT, THE LEFT INTERNAL ILIAC ARTERY (IIA) WAS UNINTENTIONALLY COVERED BY THE CONTRALATERAL LEG COMPONENT (CAUSE OF VESSEL COVERAGE NOT REPORTED). ALTHOUGH THE LEFT IIA WAS PARTIALLY COVERED BY THE DEVICE, THERE WAS REPORTEDLY NO OBSTRUCTION OF BLOOD FLOW; THEREFORE, NO ADDITIONAL TREATMENT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13002709 ↗
• InjuryDec 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, FOLLOW-UP EXAMINATION REPORTEDLY REVEALED ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) AND A DISTAL TYPE I ENDOLEAK ON THE LEFT SIDE. ON (B)(6) 2021, A REINTERVENTION PROCEDURE WAS PERFORMED WHEREBY THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND ADDITIONAL STENT GRAFTS WERE PLACED TO EXTEND DISTALLY. THE ENDOLEAK WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 12990991 ↗
• InjuryJun 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING APPROXIMATELY 45MM IN DIAMETER, AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IN THE BEGINNING OF (B)(6) 2020, FOLLOW-UP IMAGING REVEALED ANEURYSM ENLARGEMENT TO APPROXIMATELY 60 MM IN DIAMETER AND A TYPE II ENDOLEAK FROM THE L4 LUMBAR ARTERY. ADDITIONALLY, A PROXIMAL TYPE I ENDOLEAK WAS DETERMINED ALONG WITH A TYPE III ENDOLEAK DUE TO COMPONENT DISCONNECT OF THE CONTRALATERAL LEG COMPONENT FROM THE CONTRALATERAL GATE. ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED AND AN ENDURANT CUFF WAS PLACED TO TREAT THE PROXIMAL TYPE I ENDOLEAK, AND A CONTRALATERAL LEG COMPONENT WAS PLACED TO TREAT AND RELINE THE TYPE III ENDOLEAK. NO TREATMENT FOR THE TYPE II ENDOLEAK WAS PERFORMED BUT FUTURE TREATMENT IS PLANNED. THE TYPE I ENDOLEAK WAS REPORTED TO HAVE NOT BEEN RESOLVED BY PLACEMENT OF THE ENDURANT CUFF. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10108639 ↗
• InjurySep 12, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, ESTIMATED TO BE ON OR ABOUT (B)(6) 2011; ENLARGEMENT OF THE RIGHT COMMON ILIAC ARTERY WAS NOTED AND THOUGHT TO BE DUE TO THE DISTAL END OF THE CONTRALATERAL LEG COMPONENT APPEARING TO LACK CIRCUMFERENTIAL APPOSITION TO THE VESSEL WALL. ON (B)(6) 2019, THE PATIENT UNDERWENT RE-INTERVENTION AND AN ADDITIONAL STENT GRAFT WAS IMPLANTED TO EXTEND THE COVERAGE TO THE RIGHT EXTERNAL ILIAC ARTERY, WITH INTENTIONAL COVERAGE OF THE RIGHT INTERNAL ILIAC ARTERY. IT WAS REPORTED THAT NO EMBOLIZATION OF THE PATIENT¿S RIGHT INTERNAL ILIAC ARTERY WAS PERFORMED AS THE PATIENT HAD A PRE-EXISTING STENOSIS OF THE RIGHT INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE WITH TWO TYPE II ENDOLEAKS NOTED FROM UNKNOWN SOURCES AT THE CONCLUSION. THE PHYSICIAN WILL MONITOR THE TYPE II ENDOLEAKS.

  Patient problems: Aneurysm

  MAUDE report 9013537 ↗
• InjuryJul 31, 2019Malposition of Device; Malposition of Device

  ON (B)(6) 2006, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A RUPTURED AAA IN THE LEFT COMMON ILIAC ARTERY. IMAGES REVEALED THE CONTRALATERAL LEG ENDOPROSTHESIS (PXC201200/04595219) WAS FREE FLOATING IN THE ANEURYSM SAC AND HAD MIGRATED OUT OF THE ILIAC ARTERY, WHICH WAS ALSO ANEURYSMAL AT TIME OF IMPLANT. THE PHYSICIAN CHOSE TO EMBOLIZE THE LEFT INTERNAL ILIAC ARTERY AND EXTEND WITH A CONTRALATERAL LEG ENDOPROSTHESIS (PLC121400/20227629) INTO THE LEFT EXTERNAL COMMON ILIAC ARTERY. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8847384 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis
• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)