AFX Endovascular AAA System IS20-25/C55 SARecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00818009011466), received between Feb 29, 2016 and Aug 17, 2023 — classified as 13 injuries.

The most frequently reported specific device problem is “Leak/Splash” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 17, 2023Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL PROXIMAL EXTENSION AND THREE (3) AFX LIMB STENT GRAFT DISTAL EXTENSIONS. APPROXIMATELY THREE (3) MONTHS POST INITIAL IMPLANT PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA AND CT (COMPUTED TOMOGRAPHY) DETECTED A TYPE IB ENDOLEAK FROM THE RIGHT COMMON ILIAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX LIMB STENT GRAFT WITH TWO (2) OVATION IX EXTENDERS ON (B)(6) 2020. THE PATIENT WAS REPORTEDLY IN STABLE CONDITION POST RE-INTERVENTION. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THE INITIAL PROCEDURE WAS OFF-LABEL DUE TO THE RIGHT ILIAC ARTERY: THE ANEURYSM EXTENDED INTO BILATERAL ILIACS AND THERE WAS NOT AN ADEQUATE DISTAL FIXATION LENGTH, AS 15MM ABOVE THE RIGHT INTERNAL ILIAC ARTERY THE VESSEL WAS ANEURYSMAL AT 23.8MM (IFU REQUIREMENT IS 10-23MM). REFERENCE MFR. REPORT # 3008011247-2020-00046 FOR INITIAL REPORT TO THIS EVENT (PATIENT ID (B)(6) SUBMITTED ON 23 MARCH 2020. AS THE CFN/FEI # WAS INCORRECT ON REPORT 3008011247-2020-00046 DUE TO AN AFX PRIMARY PRODUCT, THIS INITIAL/F

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 17563866 ↗
• InjuryDec 3, 2021Off-Label Use; Appropriate Device Problem Term/Code Not Available; Off-Label Use; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL AND AN AFX LIMB STENT GRAFT. APPROXIMATELY TWO AND A HALF (2.5) YEARS POST INITIAL PROCEDURE ROUTINE FOLLOW UP COMPUTED TOMOGRAPHY IDENTIFIED ANEURYSM ENLARGEMENT AND A TYPE IB ENDOLEAK OF BOTH ILIAC LIMBS. REINTERVENTION IS SCHEDULED; HOWEVER, HAS NOT YET TAKEN PLACE. THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 12924419 ↗
• InjuryApr 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, TWO (2) SUPRARENAL STENT GRAFT EXTENSIONS AND A LIMB GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, AT THE END OF THE PROCEDURE AN ANGIOGRAM WAS PERFORMED AND AN INTRAOPERATIVE 1B ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. APPROXIMATELY, 1 MONTH POST INITIAL PROCEDURE A RE-INTERVENTION WAS COMPLETED TO RESOLVE THE ENDOLEAK AND PATIENT WAS TREATED WITH A NON- ENDOLOGIX STENT (PXC121000 LEFT) , AND COIL EMBOLIZATION. NOTE: APPROXIMATELY 2 YEARS POST RE-INTERVENTION A SMALL TYPE 2 ENDOLEAK (NON DEVICE REALTED) WAS IDENTIFIED TO THE RIGHT OF THE DISTAL AORTIC STENT GRAFT. REPORTEDLY, PATIENT REFUSED RE-INTERVENTION AND WAS REFERRED TO HOSPICE. PATIENT WAS ADVISED THAT AN UNTREATED TYPE 2 ENDOLEAK CAN RUPTURE AND CAUSE DEATH. PATIENT EXPIRED ON (B)(6) 2018; NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 11720644 ↗
• InjuryJul 23, 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 AFX BIFURCATED STENT GRAFT, AN AFX VELA SUPRARENAL, AND TWO (2) AFX LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 3.5 YEARS POST INITIAL PROCEDURE, DURING A SURVEILLANCE CT (COMPUTED TOMOGRAPHY), A TYPE 1B ENDOLEAK WITH AN EXPANDING COMMON ILIAC ARTERY ANEURYSM IN THE RIGHT ILIAC WAS IDENTIFIED. AN INTERVENTION WAS COMPLETED. THE PHYSICIAN ELECTED TO TREAT THE TYPE 1B ENDOLEAK AND ANEURYSM EXPANSION WITH IMPLANT OF AN AFX VELA INFRARENAL, AND TWO (2) ADDITIONAL AFX LIMB STENT GRAFT EXTENSIONS. PATIENT DID WELL DURING PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 10316877 ↗
• InjuryMar 23, 2020Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) MONTHS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED AAA AND CT (COMPUTED TOMOGRAPHY) DETECTED A TYPE IB ENDOLEAK FROM THE RIGHT COMMON ILIAC. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING AN ADDITIONAL AFX LIMB STENT GRAFT WITH TWO (2) OVATION IX EXTENDER DEVICES ON (B)(6) 2020. THE PATIENT IS REPORTEDLY IN STABLE CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THE INITIAL PROCEDURE WAS OFF LABEL DUE TO THE RIGHT ILIAC ARTERY AS THE ANEURYSM EXTENDED INTO BILATERAL ILIACS AND THERE WAS NOT AN ADEQUATE DISTAL FIXATION LENGTH (AT 15MM ABOVE RIGHT INTERNAL ILIAC ARTERY THE VESSEL WAS ANEURYSMAL AT 23.8MM (SHOULD BE 10-23MM).

  Patient problems: Failure of Implant; Rupture

  MAUDE report 9869447 ↗
• InjuryAug 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, AN INFRARENAL EXTENSION AND (2) LIMB EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). REPORTEDLY, DURING A 3 YEAR ROUTINE FOLLOW UP A COMPUTERIZED TOMOGRAPHY (CT) IDENTIFIED A TYPE 1B ENDOLEAK. THE PHYSICIAN ELECTED TO TREAT WITH AN OVATION IX EXTENDER AND AN AFX LIMB STENT GRAFT. INTERVENTION WENT WELL AND PATIENT IS DOING FINE.

  Patient problems: Failure of Implant

  MAUDE report 8947006 ↗
• InjuryJan 11, 2019Loss of or Failure to Bond; Leak/Splash; Improper or Incorrect Procedure or Method; Loss of or Failure to Bond; Leak/Splash; Improper or Incorrect Procedure or Method

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND TWO (2) LIMB STENT GRAFTS TO TREAT AN ILIAC ANEURYSM. THE PATIENT HAS A FUSIFORM ANEURYSM MORE PROXIMALLY BUT THIS WAS NOT TREATED. THE SURGEON REPORTS THAT DURING THE PROCEDURE THE LEFT LIMB EXTENSION WAS DEEMED TO NOT HAVE ENOUGH OVERLAP WITH THE MAIN BODY. A BRIDGING STENT WAS PLACED AND IT WAS THOUGHT THAT THIS ADDRESSED THE PROBLEM. HOWEVER, APPROXIMATELY NINE (9) MONTHS POST INITIAL PROCEDURE, A TYPE 1B ENDOLEAK WAS SUSPECTED. THE PHYSICIAN PLANS TO RE-INTERVENE AND WILL CONTINUE TO MONITOR THE PATIENT.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 8242220 ↗
• InjuryNov 1, 2018Leak/Splash; Leak/Splash

  THE PATIENT WAS PREVIOUSLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSIONS AND A LIMB EXTENSION STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (4) MONTH POST INITIAL IMPLANT, A TYPE 1B ENDOLEAK (DISTAL ILIAC LEAK FROM THE LEFT ILIAC) WAS DISCOVERED DURING A ROUTINE FOLLOW UP. AN INTERVENTION IS SCHEDULED FOR (B)(6) 2018. THE PATIENT IS REPORTED AS STABLE AND THE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8030605 ↗
• InjuryJul 20, 2018Loss of or Failure to Bond; Leak/Splash; Loss of or Failure to Bond; Leak/Splash

  THE PATIENT WAS INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IB ENDOLEAK DETECTED ON CT. RE-INTERVENTION IS PLANNED BUT HAS NOT BEEN SCHEDULED. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 7707372 ↗
• InjuryFeb 21, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  ON (B)(6) 2016, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL EXTENSION AND TWO (2) LIMB EXTENSIONS. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A 3A ENDOLEAK WITH GRAFT MOVEMENT ON THE SUPRARENAL EXTENSION AND 1B ENDOLEAK ON THE LEFT LIMB. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ABDOMINAL PAIN. THE PHYSICIAN ELECTED TO IMPLANT TWO (2) ADDITIONAL EXTENSIONS TO ADDRESS THE 3A ENDOLEAK / GRAFT MOVEMENT AND IMPLANT AN OVATION LIMB EXTENSION TO ADDRESS THE 1B ENDOLEAK. THE PATIENT WAS REPORTED AS STABLE POST-SECONDARY PROCEDURE. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE THAT THE PATIENT HAD EXPIRED ABOUT A WEEK POST-SECONDARY PROCEDURE. THE PHYSICIAN DID NOT PROVIDE AN EXACT DATE OR CAUSE OF DEATH. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME. THIS MDR (2031527-2018-00105) WILL COVER THE 1B ENDOLEAK OF THE LEFT LIMB. A SEPARATE MDR (2031527-2018-00104) WILL COVER THE 3A ENDOLEAK WITH GRAFT MOVEMENT OF THE SUPRARENAL EXTENSION AS WELL AS THE REPORTED DEATH.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7286448 ↗
• InjuryJan 5, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  ON (B)(6) 2016, THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT, A SUPRARENAL EXTENSION AND A LIMB STENT GRAFT. ON (B)(6) 2017, DURING A ROUTINE FOLLOW UP, SAC GROWTH WITH A POSSIBLE 1B ENDOLEAK WAS DISCOVERED. ON (B)(6) 2017, THE PHYSICIAN ELECTED TO IMPLANT ANOTHER LIMB STENT GRAFT TO SEAL THE LEAK. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7167683 ↗
• InjuryJun 22, 2017Leak/Splash; Leak/Splash

  PATIENT INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT, A SUPRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS ON (B)(6) 2016. A FOLLOW UP COMPUTED TOMOGRAPHY (CT) SHOWED THE PATIENT HAD A POTENTIAL TYPE 1B OR TYPE 3A ENDOLEAK WITH ANEURYSM SAC GROWTH. ON (B)(6) 2017 THE PHYSICIAN COMPLETED AN ANGIOGRAM AND CONFIRMED THE PATIENT HAD A TYPE 1B ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL LIMB EXTENSION TO SEAL THE ENDOLEAK. IT WAS REPORTED THE PATIENT STILL HAD AN ENDOLEAK FOLLOWING THE SECONDARY PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 6662389 ↗
• InjuryFeb 29, 2016Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  PATIENT HAD AN EMERGENT RUPTURE AND WAS INITIALLY IMPLANTED WITH A BIFURCATED, TWO INFRARENAL AORTIC EXTENSIONS, A SUPRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION ON (B)(6) 2016. THE PATIENT CAME IN EMERGENTLY ON (B)(6) 2016 WITH ABDOMINAL PAIN AND COMPUTED TOMOGRAPHY REVEALED POSSIBLE ENDOLEAK. PATIENT WAS ADMITTED AND AN ANGIOGRAM CONFIRMED TYPE 1B ENDOLEAK WITH SAC GROWTH. PHYSICIAN ELECTED TO IMPLANT COMPETITOR DEVICE TO SEAL THE ENDOLEAK. PATIENT IS IN STABLE CONDITION.

  Patient problems: Aneurysm; Blood Loss; Failure of Implant; Intimal Dissection; Rupture

  MAUDE report 5466247 ↗

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-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-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-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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-0595-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL

…and 1 more.