AFX Endovascular AAA System I16-16/C88 SARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00818009011404), received between Feb 19, 2016 and Jan 23, 2019 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2019Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT, AND SNORKEL OF THE LEFT INTERNAL ILIAC (OFF-LABEL). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN; CTA DETECTED A CONTAINED RUPTURE OF THE RIGHT ILIAC ANEURYSM AND GRAFT THROMBUS ON THE LEFT SIDE, WITH NO ENDOLEAK. ALSO, THE PATIENT WAS REPORTEDLY NON-COMPLIANT WITH FOLLOW-UPS. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY CONVERTING TO OPEN REPAIR ON (B)(6) 2018. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

  Patient problems: Abdominal Pain; Pain; Rupture; Thrombus

  MAUDE report 8272262 ↗
• InjuryJan 24, 2018Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS INITIALLY IMPLANTED WITH AFX DEVICES TO REPAIR AN ABDOMINAL AORTIC ANEURYSM AND A COMMON ILIAC ARTERY ANEURYSM. DURING THE IMPLANT PROCEDURE THE PHYSICIAN HAD DIFFICULTY WITH DEPLOYING THE LIMB EXTENSION. IT WAS REPORTED THERE WAS RESISTANCE WHEN RETRACTING THE DELIVERY SYSTEM OF THE DEVICE. ADDITIONAL TROUBLESHOOTING WAS COMPLETED AND AT THE CONCLUSION OF THE DEPLOYMENT OF THE LIMB THE LANDING ZONE WAS MISSED. THE LIMB EXTENSION LANDED LOWER THEN INTENDED CAUSING THE INTERNAL ILIAC ARTERY TO BE COVERED. THE PHYSICIAN HAD TO IMPLANT ADDITIONAL LIMB EXTENSIONS TO RESOLVE THE ISSUE. THE INITIAL PROCEDURE WAS COMPLETED AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7217096 ↗
• DeathOct 16, 2017Hole In Material; Off-Label Use; Improper or Incorrect Procedure or Method; Malposition of Device; Device-Device Incompatibility; Hole In Material; Off-Label Use; Improper or Incorrect Procedure or Method; Malposition of Device; Device-Device Incompatibility

  THE PATIENT UNDERWENT EVAR WITH AFX2 PRODUCT. AT THE CONCLUSION OF THE CASE THE PHYSICIAN ELECTED TO USE A COOK CODA (COMPLIANT) BALLOON TO BALLOON INSIDE THE GRAFT AT THE PROXIMAL, MIDDLE AND DISTAL END OF THE GRAFT; OVERLAP POINTS. IT WAS REPORTED THE PHYSICIAN DID NOT USE AN INDEFLATOR TO MEASURE THE PRESSURE IN THE BALLOON. UPON BALLOONING A NARROWING IN THE RIGHT ILIAC LIMB GRAFT, IT WAS NOTED THAT THE BALLOON WAS PLACED APPROXIMATELY (B)(4) OUTSIDE OF THE GRAFT LIMB, AND PATIENTS RIGHT COMMON ILIAC ARTERY POTENTIALLY RUPTURED. IMMEDIATE ACTION WAS TAKEN TO TAPENADE THE BLOOD LOSS BY INFLATING THE CODA BALLOON PROXIMAL THE RIGHT ILIAC ARTERY, AND THE PATIENT WAS STABILIZED. SEVERAL ATTEMPTS WERE MADE TO IDENTIFY THE EXACT LOCATION OF THE BLOOD LOSS; AN ADDITIONAL ILIAC LIMB GRAFT (OVATION IX), WAS IMPLANTED IN AN ATTEMPT TO SEAL THE SUSPECTED RUPTURE. THE PHYSICIAN THEN ELECTED TO CONVERT TO OPEN SURGICAL REPAIR; HOWEVER, THE PATIENT EXPIRED DURING THE EXPLANT PROCEDURE.

  Patient problems: Death; Perforation of Vessels; Rupture

  MAUDE report 6952828 ↗
• InjuryFeb 24, 2017Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash

  IT WAS REPORTED THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2014 WITH A BIFURCATED, AN INFRARENAL AORTIC EXTENSION, A SUPRARENAL AORTIC EXTENSION, AND A LIMB STENT GRAFT. ON (B)(6) 2015 THE PATIENT HAD A SUBSEQUENT ENDOVASCULAR PROCEDURE TO REPAIR A TYPE 1B ENDOLEAK, TWO LIMB STENTS WERE PLACED IN THE RIGHT ILIAC ARTERY. ON (B)(6) 2017 THE PATIENT CAME IN EMERGENTLY WITH PAIN, COMPUTED TOMOGRAPHY (CT) SHOWED AN EXPANDING ILIAC ANEURYSM IN THE LEFT ILIAC ARTERY. THE PHYSICIAN ELECTED TO IMPLANT A NON-ENDOLOGIX DEVICE AS A LEFT LIMB EXTENSION (MEDTRONIC AUI). AT THE COMPLETION OF THE INTERVENTION THE PHYSICIAN NOTED A TYPE 3A ENDOLEAK BETWEEN THE MAIN BODY AND THE NON-ENDOLOGIX STENT. THE PATIENT WILL BE MONITORED AND IS SCHEDULED TO RETURN FOR A 30-DAY CT. IT HAS BEEN REPORTED THE PATIENT WAS IN STABLE CONDITION AT THE COMPLETION OF THE PROCEDURE.

  Patient problems: Aneurysm; Failure of Implant; Pain; Rupture

  MAUDE report 6358518 ↗
• InjuryFeb 19, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

  PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT AND THREE LIMB EXTENSIONS ON (B)(6) 2015. UPON FOLLOW-UP, COMPUTED TOMOGRAPHY (CT) REVEALED A TYPE 1B ENDOLEAK ON THE RIGHT LIMB. THE PHYSICIAN ELECTED TO IMPLANT A LIMB EXTENSION AS WELL AS AN ADDITIONAL COMPETITOR DEVICE TO RESOLVE THE ENDOLEAK. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 5448900 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-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-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-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-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-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-0592-06 · 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.