GORE EXCLUDER AAA Endoprosthesis PXT231414Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00733132610143), received between Feb 1, 2019 and Oct 15, 2025 — classified as 1 death, 16 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Migration; Device Endoleak; Migration; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: IN 2006, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE®EXCLUDER®AAA ENDOPROSTHESIS. IN (B)(6) 2025, THE PATIENT HAD A FALL. DURING A CT SCAN AT THE HOSPITAL, IT WAS NOTICED THAT THE PATIENT HAD A TYPE 1A ENDOLEAK. ON (B)(6) 2025, THE PATIENT HAD A REINTERVENTION, WITH A PROXIMAL CUFF EXTENSION BEING PLACED. THIS SUCCESSFULLY RESOLVED THE TYPE 1A ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE PHYSICIAN BELIEVES THE GRAFT MAY HAVE MIGRATED, AS THE PROXIMAL END OF THE GRAFT IS 1CM DISTAL TO THE RENAL ARTERIES; AND THAT THE POTENTIAL MIGRATION MAY BE CAUSED BY DEGENERATION OF THE PROXIMAL NECK. HOWEVER, THIS REMAINS UNKNOWN.

  Patient problems: Clinical Endoleak

  MAUDE report 23289897 ↗
• InjuryOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2007, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, FOLLOW-UP COMPUTED TOMGRAPHY (CT) DETERMINED ENLARGEMENT OF THE ANEURYSM FROM 5.7CM TO 7.0CM AND A SUSPECTED TYPE II ENDOLEAK FROM A LUMBAR ARTERY. ON (B)(6) 2024, THE PATIENT UNDERWENT REINTERVENTION FOR A SUSPECTED PROXIMAL TYPE I ENDOLEAK AND A GORE® EXCLUDER® AAA AORTIC EXTENDER WAS IMPLANTED PROXIMALLY. THE PHYSICIAN WAS UNABLE TO CONFIRM THE TYPE I-A ON ANGIO BUT TYPE I-A WAS STILL SUSPECTED FROM COMPUTED TOMOGRAPHY. THE CASE WAS TECHNICALLY SUCCESSFUL AND THE PHYSICIAN WILL CHECK THE ENDOLEAK ON A FOLLOW UP CT AT A LATER DATE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 20510379 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Device Endoleak; Adverse Event Without Identified Device or Use Problem; Device Endoleak

  IT WAS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED ON (B)(6) 2010, IN ORDER TO TREAT A 50 MM ABDOMINAL AORTIC ANEURYSM IN A PATIENT AT IMPLANTATION. AT THE FIRST ANGIOGRAPHIC CHECK-UP ON (B)(6) 2011, A TYPE II ENDOLEAK WAS VISIBLE IN THE POSTERIOR AND SUPERIOR PART OF THE ANEURYSM SAC IN RELATION TO A LUMBAR ARTERY. THIS TYPE II ENDOLEAK FROM THE LUMBAR ARTERIES PROGRESSED, RESULTED IN AN ENLARGED ANEURYSM SAC MEASURING 87 MM. ON (B)(6) 2024, AFTER ABOUT 13 YEARS 5 MONTHS, THE ENDOPROTHESIS WAS EXPLANTED.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19816101 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), 2008, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2024, A REINTERVENTION WAS PERFORMED DUE TO ANEURYSM ENLARGEMENT WHICH FOUND DURING A FOLLOW-UP EXAMINATION. SURGICAL ANEURYSMORRHAPHY WAS PERFORMED. THE PATIENT¿S OUTCOME WAS NOT REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm expansion

  MAUDE report 18604235 ↗
• InjuryJul 25, 2022Migration; Migration

  THE FOLLOWING LITERATURE ARTICLE WAS REVIEWED: BONARDELLI, S., VERZINI, F., RIVOLTA, N., PAGLIARICCIO, G., ZANOTTI, C., BOERO, M., FRANCHIN, M., CARBONARI, L., BAGGI, P., GIBELLO, L., PARLANI, G., CAVI, R. AND PIFFARETTI, G. (2022). 'LONG-TERM OUTCOMES OF ENDOVASCULAR AORTIC REPAIR WITH FLARED ILIAC LIMB ENDOGRAFTS IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSM AND ANEURYSMAL COMMON ILIAC ARTERIES', J CARDIOVASC SURG (TORINO), 63(4), PP. 464-470. THE AIM OF THIS STUDY WAS TO EVALUATE MID-TO-LONG-TERM OUTCOMES OF ENDOVASCULAR ANEURYSM REPAIR USING FLARED ILIAC LIMB GRAFTS IN PATIENTS WITH ABDOMINAL AORTIC ANEURYSM (AAA) AND ANEURYSMAL COMMON ILIAC ARTERIES (CIAS). THIS IS A MULTICENTER, RETROSPECTIVE, OBSERVATIONAL COHORT STUDY THAT INVOLVES FOUR TERTIARY REFERRAL HOSPITALS BETWEEN MAY 1, 2005 AND APRIL 30, 2019. 995 ANEURYSMAL ILIAC LIMBS IN 795 PATIENTS WHO MET THE INCLUSION CRITERIA WERE INVOLVED IN THE STUDY. OUT OF THESE 795 PATIENTS, 471 PATIENTS WERE TREATED WITH ZENITH ALPHA¿ (COOK), 180 PATIENTS WITH ENDURANT¿ (MEDTRONIC), AND 144 PATIENTS WERE TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. IT WAS ADDITIONALLY REPORTED BY THE CORRESPONDING AUTHOR, THAT A TOTAL OF 90 PATIENTS

  Patient problems: Aneurysm; Aneurysm expansion; Clinical Endoleak

  MAUDE report 15091681 ↗
• InjuryDec 14, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. A TYPE II ENDOLEAK WAS REPORTEDLY OBSERVED ON A FINAL PROCEDURAL ANGIOGRAPH. THE PHYSICIAN ELECTED TO MONITOR ENDOLEAK, AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, A FOLLOW-UP EXAMINATION REPORTEDLY SHOWED ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) DUE TO A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY. ON (B)(6) 2021, COIL EMBOLIZATION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 13002428 ↗
• InjuryOct 22, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, AN ANEURYSM ENLARGEMENT AND A TYPE II ENDOLEAK FROM THE INFERIOR MESENTERIC ARTERY WAS OBSERVED. ON AN UNKNOWN DATE, REINTERVENTION TOOK PLACE, THE INFERIOR MESENTERIC ARTERY WAS COIL EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 12682029 ↗
• InjuryApr 26, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A FOLLOW-UP IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK AND THE ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). IT WAS REPORTED THAT THE CAUSE OF THE ENDOLEAK WAS ANEURYSMAL DILATATION OF THE PROXIMAL NECK. ON (B)(6) 2021, A RE-INTERVENTION WAS PERFORMED TO TREAT THE PROXIMAL TYPE I ENDOLEAK WHEREAS AN ADDITIONAL STENT GRAFT WAS IMPLANTED FOR PROXIMAL EXTENSION. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 11724466 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, A FOLLOW-UP IMAGING IDENTIFIED A TYPE II ENDOLEAK ORIGINATING FROM LUMBER ARTERY AND THE ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). ON (B)(6) 2016, A RE-INTERVENTION WAS PERFORMED TO TREAT THE TYPE II ENDOLEAK WHEREAS THE LUMBER ARTERY WAS COIL-EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 11724356 ↗
• InjuryFeb 8, 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) 2013, 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, A TYPE II ENDOLEAK AND ANEURYSM ENLARGEMENT WERE OBSERVED. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND A LUMBAR ARTERY WAS COIL EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019, THE PATIENT UNDERWENT REINTERVENTION AND A SECOND LUMBAR ARTERY UNDERWENT EMBOLIZATION USING N-BUTYL-2-CYANOACRYLATE. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, ENLARGEMENT OF THE ANEURYSM PERSISTED, A TYPE I ENDOLEAK OR TYPE II ENDOLEAK WERE SUSPECTED. ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN CONVERSION. THE ANEURYSM SAC WAS RESECTED. THE TRUNK - IPSILATERAL LEG ENDOPROSTHESIS WAS CUT JUST ABOVE THE FLOW DIVIDER, AND THE LUMBAR ARTERY WAS LIGATED. STUMP PLASTY OF THE DEVICE WAS PERFORMED, AND IT WAS ANASTOMOSED TO THE Y-SHAPED GRAFT. THE DISTAL SIDES OF THE Y-SHAPED GRAFT WAS ANASTOMOSED TO THE NATIVE BLOOD VESSELS OF THE BILATERAL COMMON ILIAC ARTERIES. THE INFERIOR MESENTERIC ARTERY WAS ANASTOMOSED TO THE LE

  Patient problems: Aneurysm

  MAUDE report 11293421 ↗
• InjuryNov 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AN UNKNOWN DATE AROUND IN 2008, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE AFTER THE PROCEDURE, THE ANEURYSM ENLARGEMENT WAS CONFIRMED. THE CAUSE OF THE ANEURYSM ENLARGEMENT WAS UNKNOWN. TYPE II OR TYPE IA OR TYPE III ENDOLEAK WERE NOT DENIED BUT NOT CONFIRMED FROM THE CT IMAGES. PALMAZ STENT XL WAS FOUND A LACK OF APPOSITION AT THE PROXIMAL NECK DUE TO THE PROXIMAL NECK ENLARGEMENT. REPORTED THE OPEN PROCEDURE IS PLANNING.

  Patient problems: Aneurysm

  MAUDE report 10771610 ↗
• DeathSep 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A TYPE II ENDOLEAK WAS DETECTED AT FINAL ANGIOGRAPHY. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN EARLY (B)(6) 2020 A PROXIMAL TYPE I ENDOLEAK, A DISTAL ENDOLEAK ON BOTH THE RIGHT AND LEFT SIDE, AND ANEURYSM ENLARGEMENT WERE CONFIRMED. A RE-INTERVENTION AND ADDITIONAL STENT GRAFT PLACEMENT ON BOTH THE PROXIMAL AND DISTAL SIDES WAS PLANNED FOR (B)(6) 2020. HOWEVER, ON AN UNKNOWN DATE IN MID (B)(6) 2020 (REPORTED AS AROUND (B)(6)) THE PATIENT EXPIRED DUE TO ANEURYSM RUPTURE. IT WAS REPORTED THAT THE ATTENDING PHYSICIAN WAS UNABLE TO OBTAIN DETAILED INFORMATION REGARDING THE PATIENT'S DEATH.

  Patient problems: Aneurysm; Death; Perforation of Vessels

  MAUDE report 10525800 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. ON (B)(6) 2020, RE-INTERVENTION PLACING ADDITIONAL STENT GRAFT WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10483310 ↗
• InjuryJul 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (MAXIMUM DIAMETER OF THE ANEURYSM WAS 47MM) USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN 2019, THE ANEURYSM ENLARGEMENT WAS OBSERVED (AMOUNT UNKNOWN). THE PATIENT PRESENTED WITH SHOCK DUE TO THE ALLERGIC REACTION TO CONTRAST DYE. THE CONTRAST DYE COULD NOT BE USED FOR THIS PATIENT, SO THE PHYSICIAN DECIDED TO PERFORM A FOLLOW-UP EXAM USING PLAIN COMPUTED TOMOGRAPHY (CT). ON AN UNKNOWN DATE IN 2020, THE FOLLOW-UP EXAM IDENTIFIED THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 79MM. THE ROOT CAUSE OF THE ANEURYSM ENLARGEMENT WAS UNKNOWN BECAUSE THE ANGIOGRAPHY IMAGING WAS NOT ABLE TO BE TAKEN. THE PHYSICIAN PLANNED TO DO OPEN SURGERY TO TREAT THE ANEURYSM ENLARGEMENT, BECAUSE THIS PATIENT CANNOT TAKE AN ENDOVASCULAR TREATMENT DUE TO ALLERGY OF CONTRAST DYE. ON (B)(6) 2020, THE GORE® EXCLUDER® AAA ENDOPROSTHESES WERE EXPLANTED AND THE ABDOMINAL AORTA WAS REPLACED AS Y GRAFT. DURING THE PROCEDURE, A PROXIMAL TYPE I ENDOLEAK WAS SLIGHTLY CONFIRMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10291687 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. OP NOTES PROVIDED FOR CURRENT REINTERVENTION REVEALED THERE WAS A REINTERVENTION IN EARLY 2019. THE PHYSICIAN EXTENDED THE LEFT LIMB OF THE ENDOPROSTHESIS (IT IS UNKNOWN WHICH DEVICE WAS IN THE LEFT LIMB AND REINTERVENED ON) INTO THE EXTERNAL ILIAC ARTERY TO PROVIDE BETTER SEAL AND DID A TRANSCAVAL COILING WHERE FLOW CHANNEL WAS ACCESSED AND TREATED. THE PATIENT TOLERATED THIS REINTERVENTION. THERE WAS ANEURYSM SAC ENLARGEMENT WITH AN UNKNOWN CAUSE. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY IS UNKNOWN) REVEALED A POSSIBLE TYPE II ENDOLEAK AND ANEURYSM SAC ENLARGEMENT. ON (B)(6) 2019, THERE WAS A REINTERVENTION. THE PHYSICIAN CHOSE TO RELINE THE GORE® EXCLUDER® AAA ENDOPROSTHESIS AND ANCHOR PROXIMALLY. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 9207756 ↗
• InjuryMar 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. A FINAL ANGIOGRAPHY IDENTIFIED A TYPE II ENDOLEAK OF AN UNKNOWN ORIGIN. THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE, THE FOLLOW-UP IMAGING IDENTIFIED THE ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). THE PATIENT WAS REFERRED TO THE COMPLAINANT INSTITUTION FOR FURTHER EXAMINATION. ON AN UNKNOWN DATE, THE FOLLOW-UP IMAGING IDENTIFIED A DISTAL TYPE I ENDOLEAK FROM THE CONTRALATERAL LEG COMPONENT (PXC141000/9814440) ON THE RIGHT SIDE. IT WAS UNKNOWN IF THE TYPE II ENDOLEAK IDENTIFIED DURING THE INITIAL PROCEDURE WAS RESOLVED AT THIS TIME. REPORTEDLY, THE PHYSICIAN COULD NOT DETERMINE WHAT CAUSED THE DISTAL TYPE I ENDOLEAK AND THE ANEURYSM ENLARGEMENT. THE CLINICAL SPECIALIST WAS CONCERNED WITH THE PERSISTENT TYPE II ENDOLEAK CONTRIBUTING TO THE DISTAL TYPE I ENDOLEAK. ON (B)(6) 2019, THE PATIENT UNDERWENT A RE-INTERVENTION WHEREBY THE CONTRALATERAL LEG COMPONENT (RIGHT) AND THE ILIAC EXTENDER COMPONENT (LEFT) WERE IMPLANTED TO EXTEND THE INITIALLY IMPLANTED DEVICES. THE RIGHT INTERNAL ILIAC ARTERY WAS

  Patient problems: Aneurysm; No Code Available

  MAUDE report 8434745 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT COMPUTED TOMOGRAPHY (CT) IMAGES DATED (B)(6) 2018, REVEALED A POSSIBLE TYPE II ENDOLEAK. THERE IS ANEURYSM SAC ENLARGEMENT (MAX DIAMETER APPEARS TO BE 72.2MM X 82.9MM) EXACT AMOUNT IS UNKNOWN. NO REINTERVENTION IS PLANNED AT THIS TIME, THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH.

  Patient problems: Aneurysm

  MAUDE report 8297331 ↗

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