AFX2 Bifurcated Endograft System BEA28-120/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00818009014443), received between Apr 9, 2017 and Jun 3, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

16 other recalls cover devices cleared under the same FDA submission (P040002); 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY TWO YEARS POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, THE PATIENT PRESENTED WITH A TYPE IIIB ENDOLEAK. AN INTERVENTION IS PLANNED FOR ON (B)(6) 2025. THE PATIENT'S CURRENT STATUS IS REPORTED AS STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 22135089 ↗
• InjuryDec 14, 2023Lack of Effect; Lack of Effect

  THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2017 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AN AFX VELA INFRARENAL AND AN AFX LIMB STENT GRAFT. ON (B)(6) 2023, IT WAS REPORTED THAT AN INDETERMINANT ENDOLEAK WAS IDENTIFIED. ADDITIONAL INFORMATION, INCLUDING TREATMENT PLANS AND PATIENT STATUS IS PENDING.

  Patient problems: Clinical Endoleak

  MAUDE report 18328185 ↗
• InjuryJun 6, 2022Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY FIVE AND A HALF (5.5) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) AT OUTSIDE HOSPITAL WITH ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) CAN SHOWED INCREASING AAA SIZE AND WHAT APPEARED TO BE A 3B FABRIC DISRUPTION. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH ANOTHER AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO SUCCESSFULLY RESOLVE THE ENDOLEAK. THE PATIENT WAS REPORTED AS STABLE POST THIS SECONDARY PROCEDURE.

  Patient problems: Abdominal Pain; Aneurysm; Failure of Implant

  MAUDE report 14606872 ↗
• InjuryApr 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX BIFURCATED STENT GRAFT, TWO (2) AFX SUPRARENAL AORTIC EXTENSIONS, AND AN AFX LIMB STENT GRAFT. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS ADMITTED FOR AN ANEURYSM ENLARGEMENT. REINTERVENTION WAS COMPLETED TO TREAT LOSS OF OVERLAP WITH A TYPE IIIA ENDOLEAK WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. (REPORTED UNDER MFR# 2031527-2018-00163). AFTER APPROXIMATELY FOUR (4) YEARS OF POST-SECONDARY PROCEDURE, ROUTINE FOLLOW-UP IDENTIFIED A JUNCTIONAL TYPE IIIA ENDOLEAK. REINTERVENTION HAS NOT BEEN SCHEDULED. THE PATIENT IS STABLE.

  Patient problems: Failure of Implant

  MAUDE report 14106220 ↗
• InjuryJul 21, 2021Partial Blockage; Partial Blockage

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT AND (2) TWO AFX VELA SUPRARENALS. APPROXIMATELY (6) SIX MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A SIGNIFICANT CLOT THROUGHOUT THE GRAFT. THE PATIENT IS CURRENTLY IN STABLE CONDITION WITH A RE-INTERVENTION PENDING.

  Patient problems: Failure of Implant

  MAUDE report 12204245 ↗
• InjuryMar 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). IT WAS REPORTED THAT DURING THE INITIAL IMPLANT THERE WAS A PARTIAL DISSECTION OF THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN WAS ABLE TO REPAIR THE DAMAGE DURING THE INITIAL PROCEDURE. THE PATIENT IS REPORTED AS WELL. THIS EVENT WAS PREVIOUSLY REPORTED UNDER MDR # 2031527-2017-00188. NOW ON THE 48-MONTH FOLLOW-UP THERE WAS STENOSIS GREATER THAN 50% IDENTIFIED WITHIN THE BIFURCATED STENT GRAFT AND AORTIC EXTENSION STENT GRAFT. THE PATIENT'S STATUS WAS NOT REPORTED. NOTE: THIS PATIENT IS PART OF A CLINICAL STUDY CASE.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 11456467 ↗
• InjuryFeb 1, 2021Deformation Due to Compressive Stress; Insufficient Device Problem Information; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX2 BIFURCATED STENT GRAFT AND TWO (2) VELA SUPRARENAL STENT GRAFTS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, THE PATIENT PRESENTED NON SYMPTOMATIC WITH SAC ENLARGEMENT. IMAGES APPEAR TO REVEAL POTENTIAL TYPE 1A AND 3B ENDOLEAKS. RE-INTERVENTION IS PLANNED BUT HAS NOT BEEN SCHEDULED. PATIENT IS STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 11263531 ↗
• InjurySep 20, 2020Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Integrity Problem; Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Integrity Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A VELA SUPRARENAL STENT GRAFT, AND AN OVATION IX EXTENDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH AFX SYSTEM PER THE IFU. APPROXIMATELY 1 YEARS POST INITIAL IMPLANT DURING A ROUTINE COMPUTERIZED TOMOGRAPHY (CT) FOR A THORACIC ANEURYSM THE PHYSICIAN IDENTIFIED A 3B ENDOLEAK. THE PATIENT IS CURRENTLY IS STABLE AND AN INTERVENTION HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 10557991 ↗
• InjuryJul 13, 2020Improper 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

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, AND 2 (TWO) VELA SUPRARENAL STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1 (ONE) YEAR POST INITIAL PROCEDURE THE PATIENT WAS TREATED WITH IMPLANT OF AN ADDITIONAL AFX VELA SUPRARENAL STENT GRAFT EXTENSION FOR A TYPE IA ENDOLEAK, ANEURYSM ENLARGEMENT, RUPTURE, AND MIGRATION WITH OFF LABEL USE (PREVIOUSLY REPORTED UNDER MFR# 2031527-2019-00601). APPROXIMATELY 6 (SIX) MONTHS POST INTERVENTION A TYPE IA ENDOLEAK WITH RUPTURE WAS IDENTIFIED. RE-INTERVENTION COMPLETED BY EXTENDING THE SEAL ZONE BY CHIMNEY OF THE SUPERIOR MESENTERIC ARTERY WITH 4 (FOUR) AFX VELA SUPRARENAL ACHIEVING SEAL. THE PATIENT WAS SENT TO THE ICU FOR MONITORING DUE TO THE RUPTURED ANEURYSM. NO ADDITIONAL INFORMATION HAS BEEN REPORTED.

  Patient problems: Failure of Implant; Rupture

  MAUDE report 10268754 ↗
• InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A VENTANA STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) DURING AN APPROVED CLINICAL TRIAL. THE VENTANA STENT WAS NEVER RELEASED FOR SALE IN THE US. A SECONDARY PROCEDURE WAS PERFORMED TO SEAL AN ENDOLEAK OF THE VENTANA (NON - REPORTABLE). APPROXIMATELY 2.5 YEARS POST-SECONDARY PROCEDURE, PATIENT PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM AND TYPE IIIB ENDOLEAK OF THE VENTANA. AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED TO SEAL THE RUPTURE AND TYPE IIIB ENDOLEAK. NOW, 3 YEARS POST-SECONDARY PROCEDURE THE PATIENT PRESENTED EMERGENTLY, UNSTABLE WITH RUPTURED AAA. PATIENT WAS TRANSFERRED AND UNDERWENT INTERVENTION IDENTIFYING A TYPE 3A ENDOLEAK WITH JUNCTIONAL SEPARATION. SUCCESSFUL TREATMENT WAS PERFORMED WITH IMPLANT OF AN AFX VELA INFRARENAL AND AN AFX VELA SUPRARENAL. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10210119 ↗
• InjuryMar 3, 2020Use of Device Problem; Deformation Due to Compressive Stress; Insufficient Device Problem Information; Use of Device Problem; Deformation Due to Compressive Stress; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IB ENDOLEAK AS DETECTED BY CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A COVERED (NON-ENDOLOGIX) STENT A FEW DAYS LATER. A LEAK STILL APPEARED FROM THE PROXIMAL NECK (IDENTIFIED AS A TYPE IA ENDOLEAK) SO THE PHYSICIAN TREATED WITH SEVERAL COILS INSIDE THE ANEURYSM AND AT THE LEVEL OF THE NECK. THE ENDOLEAK APPEARED RESOLVED. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED PER CLINICAL EVALUATION CONFIRMING THE PRESENCE OF BUCKLING OF THE BIFURCATED STENT GRAFT.

  Patient problems: Failure of Implant

  MAUDE report 9783214 ↗
• InjuryMar 3, 2020Collapse; Use of Device Problem; Deformation Due to Compressive Stress; Collapse; Use of Device Problem; Deformation Due to Compressive Stress

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) MONTH POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IB ENDOLEAK AS DETECTED BY CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A COVERED (NON-ENDOLOGIX) STENT A FEW DAYS LATER; THIS PROCEDURE IS OFF-LABEL DUE TO USE OF AFX2 WITH A NONCOMPATIBLE, NON-ENDOLOGIX STENT. A LEAK STILL APPEARED FROM THE PROXIMAL NECK (IDENTIFIED AS A TYPE IA ENDOLEAK) SO THE PHYSICIAN TREATED WITH SEVERAL COILS INSIDE THE ANEURYSM AND AT THE LEVEL OF THE NECK. THE ENDOLEAK APPEARED RESOLVED. REFERENCE RELATED MFR. REPORT # 2031527-2020-00072 FOR THIS PREVIOUS EVENT. ANOTHER MONTH LATER, THE PATIENT PRESENTED WITH A COLLAPSED PROXIMAL PORTION OF THE BIFURCATED DEVICE WITH A PARTIAL OCCLUSION OF THE AORTA. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY CONVERTING TO OPEN SURGICAL REPAIR ON (B)(6) 2020. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant; Stenosis

  MAUDE report 9783120 ↗
• InjuryDec 12, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Migration; Use of Device Problem; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Migration

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) SUPRARENAL STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1 YEAR POST INITIAL PROCEDURE, DURING A ROUTINE FOLLOW UP, A TYPE IA ENDOLEAK WAS IDENTIFIED. PHYSICIAN ELECTED TO RESOLVED THIS EVENT BY IMPLANTING A SUPRARENAL STENT GRAFT EXTENSION. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Aneurysm; Failure of Implant; Rupture

  MAUDE report 9462349 ↗
• InjuryJun 13, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Dislodged or Dislocated; Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Device Dislodged or Dislocated

  DURING AN INITIAL IMPLANT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT, IT WAS REPORTED THAT AFTER THE DEPLOYMENT OF THE MAIN BODY THE PIG TAIL CATHETER (NON - ENDOLOGIX) BECAME STUCK. THE PHYSICIAN ELECTED TO DEPLOY THE PROXIMAL EXTENSION. THE PIG TAIL CATHETER WAS THEN ATTEMPTED TO BE REMOVE BUT WHEN PULLED THE PROXIMAL EXTENSION WAS PULLED DOWN CAUSING A LOSS OF SEAL. THE PHYSICIAN WAS UNABLE TO RECOVER THE PIG TAIL CATHETER OR RESTORE THE SEAL. THE PHYSICIAN THEN PERFORMED A LAPAROTOMY AND THE ENDOGRAFTS WERE EXPLANTED BY THE PHYSICIAN. THE PHYSICIAN COMPLETED THE REPAIR OF THE ABDOMINAL AORTIC ANEURYSM (AAA) WITH NON - ENDOLOGIX DEVICES. NO FURTHER ADDITIONAL INFORMATION OR PATIENT SEQUALAE HAS BEEN REPORTED AT THIS TIME.

  Patient problems: No Code Available; Occlusion

  MAUDE report 8696322 ↗
• InjuryJan 24, 2019Material Puncture/Hole; Stretched; Material Integrity Problem; Material Puncture/Hole; Stretched; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT CONFIRMING THAT THERE WAS NO TYPE IIIB ENDOLEAK PRESENT AT THE TIME OF THE REPORTED EVENT; RATHER, CLINICAL IDENTIFIED BILLOWING AND STENT CAGE DILATION OF THE BIFURCATED DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 8274203 ↗
• InjuryNov 14, 2018Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Material Integrity Problem

  THE PATIENT WAS INITIAL IMPLANTED ON (B)(6) 2010 WITH A BIFURCATED STENT GRAFT AND THREE (3) STENT GRAFT EXTENSIONS THE PATIENT RETURNED THREE (3) YEARS POST-INITIAL IMPLANT ((B)(6) 2013) WITH A TYPE 3A ENDOLEAK AND SECONDARY RE-INTERVENTION WAS COMPLETED WHERE AN AORTIC EXTENSION WAS PLACED. ON (B)(6) 2018, THE PATIENT WAS PRESENTED WITH A TYPE II ENDOLEAK AND ANOTHER RE-INTERVENTION OCCURRED WHERE THE STENT GRAFT WAS RELINED WITH AN AFX2 BIFURCATED STENT GRAFT AND THE BRANCHES OF THE RIGHT HYPOGASTRIC ARTERY WERE COIL EMBOLIZED. ALL OF THESE EVENT WERE PREVIOUSLY REPORTED. THE PATIENT HAS NOW PRESENTED EMERGENTLY TO THE EMERGENCY ROOM WITH PAIN, WHERE A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED SHOWING THE ANEURYSM IS 15CM IN DIAMETER IN THE PRESENCE OF A TYPE IIIB ENDOLEAK. THE PATIENT HAVE REFUSED FURTHER TREATMENT. THE PATIENT HAS HAD MULTIPLE REPAIRS WITH A RE-LINE AND HAS ELECTED TO GO INTO HOSPICE. THE PRIMARY DEVICE USED FOR THIS COMPLAINT WILL BE FROM THE LAST INTERVENTION WHERE THE ORIGINAL GRAFT WAS RELINED WITH AFX2 BIFURCATED STENT GRAFT. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant; Pain

  MAUDE report 8072156 ↗
• InjuryJun 3, 2017Difficult To Position; Malposition of Device; Difficult To Position; Malposition of Device

  DURING THE PLACEMENT OF A BIFURCATED STENT FOR A SECONDARY INTERVENTION, THE PHYSICIAN WAS UNABLE TO PLACE THE BIFURCATED STENT DIRECTLY ON THE AORTIC BIFURCATION. THE PLACEMENT OF THE MAIN BODY STENT LANDED CLOSE TO THE RENAL ARTERIES AND THE PHYSICIAN ELECTED TO IMPLANT RENAL STENTS AND SNORKEL THE RENAL ARTERIES AS A PREVENTATIVE MEASURE. THE SECONDARY INTERVENTION WAS COMPLETED AND NO ENDOLEAKS WERE OBSERVED AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT IS REPORTED TO BE DOING WELL AND THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT. THE SECONDARY PROCEDURE WAS DONE TO REPAIR A TYPE 3B ENDOLEAK WERE THE PATIENT HAD INITIALLY BEEN IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION.

  Patient problems: No Known Impact Or Consequence To Patient; Stenosis

  MAUDE report 6610160 ↗
• InjuryApr 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE INITIAL IMPLANT OF AFX DEVICES THERE WAS A PARTIAL DISSECTION OF THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN WAS ABLE TO REPAIR THE DAMAGE DURING THE INITIAL PROCEDURE. THE PATIENT IS REPORTED AS WELL.

  Patient problems: Intimal Dissection; Vascular Dissection

  MAUDE report 6521303 ↗
• InjuryApr 9, 2017Failure To Adhere Or Bond; Patient-Device Incompatibility; Failure To Adhere Or Bond; Patient-Device Incompatibility

  IT WAS REPORTED THE PATIENT HAD AN INITIAL IMPLANT WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2016 COMPUTED TOMOGRAPHY (CT) SHOWED ANEURYSM SAC GROWTH, LOSS OF OVERLAP BETWEEN THE PROXIMAL EXTENSION AND THE MAIN BODY AS WELL AS UNINTENDED MOVEMENT OF THE PROXIMAL EXTENSION. THE PATIENT REFUSED TREATMENT AT THE TIME AND A SECONDARY INTERVENTION WAS NOT COMPLETED. ON (B)(6) 2016 THE PATIENT HAD A SECONDARY INTERVENTION AND THE PHYSICIAN ELECTED TO RELINE THE INITIAL DEVICES BY IMPLANTING AN ADDITIONAL BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. A FOLLOW UP CT COMPLETED ON (B)(6) 2017 SHOWED ADDITIONAL ANEURYSM SAC GROWTH. THE PHYSICIAN IS PLANNING AN ADDITIONAL REPAIR PROCEDURE, A SUBSEQUENT ENDOVASCULAR PROCEDURE HAS NOT BEEN SCHEDULED. THE PATIENT IS REPORTED TO BE ASYMPTOMATIC AND DOING WELL.

  Patient problems: Aneurysm; Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 6474622 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040002. One submission often covers many models, so check the product and lot details in each record.

• Z-1048-2017 · Jan 4, 2017 · Terminated
  AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
• Z-1049-2017 · Jan 4, 2017 · Terminated
  AFX2 Endovascular AAA System Item No. Item Description F00820-01 BEA28-120/I20-40 F00820-02 BEA28-100/I20-40 F00820-03 BEA28-80/I20-40 F00820-06 BEA28-120/I16-40 F00820-07 B
• Z-1039-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type: IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1037-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• Z-1054-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
• Z-1047-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoili
• Z-1038-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIB; The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (A
• Z-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• Z-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
• Z-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
• Z-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• Z-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• Z-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL

…and 1 more.