AFX Endovascular AAA System IS20-25/C65 SARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00818009011473), received between Mar 23, 2017 and Apr 4, 2019 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2019Misconnection; Misconnection

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A "DISJUNCTION OF THE ILIAC EXTENSION", CHARACTERIZED AS A TYPE IIIA ENDOLEAK WITH COMPONENT SEPARATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY RELINING WITH TWO (2) ADDITIONAL LIMBS STENT AFX GRAFTS ON (B)(6) 2019. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8484535 ↗
• InjuryJun 6, 2018Failure To Adhere Or Bond; Leak/Splash; Improper or Incorrect Procedure or Method; Failure To Adhere Or Bond; Leak/Splash; Improper or Incorrect Procedure or Method

  PRIMARY PROCEDURE PERFORMED ON (B)(6) 2009, BY DR.(B)(6). A INTUITRAK BIFURCATED STENT GRAFT AND A INTUITRAK INFRARENAL AORTIC EXTENSION. SECONDARY PROCEDURE WAS PERFORMED ON (B)(6) 2018, BY DR. (B)(6), TO TREAT PROGRESSION OF LEFT COMMON ILIAC ANEURYSMAL DISEASE BEYOND ORIGINAL LIMB PLACEMENT. AN OVATION IX EXTENDER WAS PLACED AND TWO AFX LIMB EXTENSIONS WERE BRIDGED IN THE RIGHT ILIAC, AT THE TIME OF PROCEDURE THERE WAS MINIMAL OVERLAP NOTED BETWEEN THE EXTENSION IN THE RIGHT ILIAC. FOLLOW-UP COMPUTERIZED TOMOGRAPHY SCAN PERFORMED ON (B)(6) 2018, SHOWED A ENDOLEAK 3A IN THE RIGHT LIMB EXTENDING THROUGH THE COMMON ILIAC ANEURYSM. PATIENT WAS REPORTED TO BE ASYMPTOMATIC, BUT THE RIGHT COMMON ILIAC ARTERY ANEURYSM HAS ENLARGED TO 5.9CM'S. (B)(6) 2018, PATIENT INR WAS HIGH AT 2.0. TERTIARY WAS PERFORMED ON (B)(6) 2018, BY DR. (B)(6). A OVATION EXTENDER AND A OVATION ILIAC LIMB WERE IMPLANTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7572641 ↗
• InjuryApr 30, 2018Unintended Movement; Unintended Movement

  ON (B)(6) 2018 THE PATIENT VISITED THE ER AT (B)(6) MEDICAL CENTER DUE TO PAIN FROM A RETROPERITONEAL BLEED PER CTA, WITH NO OBVIOUS ENDOLEAK. THE BLEED WAS NOTED ON THE RIGHT SIDE WHERE THE PATIENT HAD A PRIOR REPAIR FOR ILIAC ANEURYSM. PATIENT WAS STABLE AND BROUGHT TO THE OR FOR AN ANGIOGRAM AND POSSIBLE REPAIR. ON ANGIOGRAM AN ENDOLEAK WAS NOT DETECTED FOR THE RIGHT OR LEFT SIDE. PER THE PHYSICIAN, PASSING A WIRE UP THROUGH THE ILIAC STENTS ON THE RIGHT SIDE WAS CHALLENGING, AND THEY NOTICED THE OVERLAP OR TRANSITION BETWEEN ONE OF THE OVERLAPPED ILIAC COMPONENTS WAS NARROWED AND "DIDN'T LOOK RIGHT," THEREFORE, THEY BALLOONED THE RIGHT ILIAC LIMB OVERLAP AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain; Rupture

  MAUDE report 7473607 ↗
• InjuryJun 2, 2017Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash; Failure To Adhere Or Bond; Detachment Of Device Component; Leak/Splash

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. A FOLLOW-UP CTA REVEALED A TYPE IIIA ENDOLEAK ON THE PATIENT'S RIGHT SIDE. FURTHER COMMUNICATION RECEIVED NOTED A TYPE II ENDOLEAK ALSO PRESENT. THE PHYSICIAN ELECTED TO RE-INTERVENE IMPLANTING TWO (2) INFRARENAL EXTENSIONS SUCCESSFULLY RESOLVING THE ENDOLEAK. AS OF DATE, NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6609956 ↗
• DeathJun 2, 2017Failure To Adhere Or Bond; Collapse; Detachment Of Device Component; Fracture; Leak/Splash; Stretched; Torn Material; Failure To Adhere Or Bond; Collapse; Detachment Of Device Component; Fracture; Leak/Splash; Stretched; Torn Material

  IT WAS REPORTED THE PATIENT HAD AN ADDITIONAL REPAIR PROCEDURE AFTER THE PLACEMENT OF THE TWO INFRARENAL AORTIC EXTENSIONS. THE PATIENT HAD A REMAINING TYPE 1A ENDOLEAK AND THE PHYSICIAN WAS UNABLE TO PLACE A NON-ENDOLOGIX STENT TO REPAIR THE LEAK. THE PATIENT EXPIRED ON (B)(6) 2017.

  Patient problems: Aneurysm; Death; Failure of Implant; Pain; Stenosis

  MAUDE report 6609926 ↗
• InjuryJun 2, 2017Failure To Adhere Or Bond; Leak/Splash; Unintended Movement; Failure To Adhere Or Bond; Leak/Splash; Unintended Movement

  THE PATIENT UNDERWENT AN INITIAL PROCEDURE WITH A BIFURCATED STENT GRAFT, FOUR (4) LIMB STENT GRAFTS AND TWO (2) OVATION ILIAC LIMBS. THE PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP, APPROXIMATELY TWO (2) MONTHS POST PROCEDURE. A TYPE IB ENDOLEAK WAS OBSERVED IN THE RIGHT ILIAC. THE PHYSICIAN ELECTED TO RE-INTERVENE APPROXIMATELY TWO (2) MONTHS POST-OP, IMPLANTING ADDITIONAL LIMB EXTENSIONS AND SUCCESSFULLY RESOLVED THE ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONE DAY POST-OP AND IS REPORTED AS WELL. THE PATIENT WILL CONTINUE TO BE MONITORED. AS OF DATE, NO ADDITIONAL PATIENT SEQUELAE HAS BEEN REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6609304 ↗
• InjuryMar 23, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND TWO LIMB STENTS. IN INVESTIGATING ANOTHER EVENT THE CLINICAL EVALUATION IDENTIFIED AN UNREPORTED SUBSEQUENT ENDOVASCULAR PROCEDURE. THE PATIENT WAS TREATED FOR A TYPE 1B ENDOLEAK WHERE THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX PALMAZ STENT. THE PHYSICIAN ADDITIONALLY COMPLETED ANGIOPLASTY ON THE RIGHT ILIAC LIMB.

  Patient problems: Failure of Implant

  MAUDE report 6429374 ↗

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-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-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-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-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-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-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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-0596-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
• Z-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-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

…and 1 more.