AFX2 Bifurcated Endograft System BEA25-60/I16-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00818009014740), received between May 16, 2018 and Dec 5, 2024 — classified as 3 deaths, 11 injuries.

The most frequently reported specific device problem is “Off-Label Use” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Off-Label Use; Material Puncture/Hole; Obstruction of Flow; Off-Label Use; Material Puncture/Hole; Obstruction of Flow

  THE PATIENT WAS TREATED FOR A DISSECTING SACCULAR ANEURYSM OF THE TERMINAL AORTA (TA) ON (B)(6) 2019. DURING THE INITIAL PROCEDURE, AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED. A BALLOON TOUCH-UP WAS PERFORMED TO ADDRESS A BIRD-BEAK CONFIGURATION. A NON-ENDOLOGIX STENT (PROTAGE 12-6.0) WAS PLACED IN THE LEFT LEG TO PREVENT OCCLUSION. THIS INITIAL PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER THE IFU. THE PROCEDURE CONCLUDED SUCCESSFULLY WITHOUT ANY SIGNS OF ENDOLEAKS. IN (B)(6) 2024, A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED THAT THERE WAS ANEURYSM DIAMETER ENLARGEMENT, FROM 38 MM IN DIAMETER TO OVER 50 MM IN DIAMETER DUE TO AN ENDOLEAK OF INDETERMINATE ORIGIN. ON (B)(6) 2024, OPEN SURGERY REPAIR WAS PERFORMED. THE AFX2 BIFURCATED STENT GRAFT WAS EXPLANTED AND CONVERTED TO A NON-ENDOLOGIX Y-SHAPED ARTIFICIAL VESSEL. IT WAS NOTED THAT MULTIPLE HOLES (TYPE IIIB ENDOLEAK) WERE FOUND IN THE AFX2 BIFURCATED STENT GRAFT. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX.

  Patient problems: Aneurysm; Clinical Endoleak; Obstruction/Occlusion

  MAUDE report 20857950 ↗
• InjurySep 28, 2023Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A COOK (NON-ENDOLOGIX) FENESTRATED DEVICE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER DEVICE IFU. APPROXIMATELY FORTY-SEVEN (47) DAYS AFTER THE INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH AN EXPANDING AAA AND ENDOLEAK TYPE IIIA. THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT. THE LEAK WAS RESOLVED, AND THE PATIENT'S CONDITION WAS REPORTED AS STABLE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17839702 ↗
• InjuryJul 18, 2023Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX LIMB STENT GRAFT DISTAL EXTENSION. APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT ROUTINE FOLLOW-UP WITH A TYPE IIIA ENDOLEAK AND IMPLANT SEPARATION AS DETECTED PER CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) ADDITIONAL AFX LIMB STENT GRAFT AND A BARD FLUENCY (NON- ENDOLOGIX) COVERED STENT 13.5X60MM ON (B)(6) 2023. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL.

  Patient problems: Clinical Endoleak

  MAUDE report 17344508 ↗
• DeathOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AFX2 BIFURCATED STENT GRAFT WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA). DURING THE PROCEDURE A RUPTURE OCCURRED. THE GRAFT WAS NOT IMPLANTED AND THERE WERE COMPLICATIONS WITH THE AORTA BEFORE IT COULD BE PLACED. THE DEVICE WAS REMOVED WITH THE SHEATH BEFORE DEPLOYMENT. THE PHYSICIAN OPTED TO PERFORM AN OPEN REPAIR. IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON THE SAME EVENING OF THE PROCEDURE. THE DEVICE WAS DISCARDED.

  Patient problems: Rupture

  MAUDE report 15576766 ↗
• InjuryAug 9, 2022Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH BACK PAIN AND A TYPE 3A ENDOLEAK WAS IDENTIFIED WITH NO ACUTE RUPTURE. THE PATIENT IS CURRENTLY BEING MONITORED WHILE AN INTERVENTION IS BEING DISCUSSED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15192678 ↗
• InjuryMay 7, 2022Off-Label Use; Off-Label Use

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE PATIENT'S PRE-EXISTING AIOD (AORTOILIAC OCCLUSIVE DISEASE). APPROXIMATELY TWO (2) HOURS POST INITIAL PROCEDURE, THE PATIENT BECAME HYPOTENSIVE WITH EVIDENCE OF EXTRAVASATION. THE ANEURYSM WAS CONFIRMED TO HAVE NOT BEEN EXCLUDED PER POST CT (COMPUTED TOMOGRAPHY) SCAN. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING THE ALTO ABDOMINAL AORTIC ANEURYSM STENT SYSTEM AND PERFORMING COIL EMBOLIZATION THE FOLLOWING DAY ON (B)(6) 2022. DURING THE SECONDARY IMPLANT PROCEDURE, THE PHYSICIAN DETERMINED THAT THE MEDIAN SACRAL WAS BACK BLEEDING INTO THE REAR OF THE AORTA DUE TO CALCIUM DEPOSITS, WHICH PIERCED THE AORTIC WALL AFTER BALLOONING THE GORE (NON-ENDOLOGIX) VBX STENTS; INITIAL IMPLANT PROCEDURE FURTHER OFF-LABEL DUE TO ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM PER IFU. THE SECONDARY RELINE WAS UNSUCCESSFUL AS THE ANEURYSM REMAINED UNEXCLUDED. THE PATIENT IS REPORTEDLY IN STABLE CONDITION AND WAS DISCHARGED.

  Patient problems: Extravasation; Low Blood Pressure/ Hypotension; Ruptured Aneurysm

  MAUDE report 14320804 ↗
• InjuryJun 25, 2021Complete Blockage; Device-Device Incompatibility; Complete Blockage; Device-Device Incompatibility

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX ILIAC LIMB TO TREAT AN ILIAC ANEURYSM. 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 TWO (2) YEARS POST INITIAL PROCEDURE, STENT THROMBOSIS THAT CAUSED OCCLUSION OF THE RIGHT AFX LIMB OF THE BIFURCATED STENT GRAFT WAS IDENTIFIED. A OPEN REPAIR WAS COMPLETED WITH A NON-ENDOLOGIX, BYPASS GRAFT. REFERENCE MFR. REPORT 3008011247-2021-00041 FOR INITIAL REPORT TO PATIENT ID (B)(6), WHICH WAS CFN/FEI # 3008011247, WHICH WAS SUBMITTED WITH THE INCORRECT CFN/FEI #.

  Patient problems: Failure of Implant

  MAUDE report 12071995 ↗
• InjuryMay 11, 2021Complete Blockage; Complete Blockage

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN OVATION IX ILIAC LIMB TO TREAT AN ILIAC ANEURYSM. 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 TWO (2) YEARS POST INITIAL PROCEDURE, STENT THROMBOSIS THAT CAUSED OCCLUSION OF THE RIGHT AFX LIMB OF THE BIFURCATED STENT GRAFT WAS IDENTIFIED. A OPEN REPAIR WAS COMPLETED WITH A NON-ENDOLOGIX, BYPASS GRAFT. ADDITIONAL INFORMATION: AFTER FURTHER REVIEW, THE INITIAL REPORT TO PATIENT ID (B)(6) WAS SUBMITTED WITH THE WRONG CFN/FEI # 3008011247, WHICH IS NOT ASSOCIATED WITH THE AFX PRODUCT LINE. THEREFORE, A CORRECTIVE INITIAL/FINAL REPORT WILL BE SUBMITTED FOR PATIENT ID (B)(6) WITH THE APPROPRIATE CFN/FEI # 2031527. PLEASE SEE MFR. REPORT # 2031527-2021-00248. THIS EVENT PER MFR. REPORT # 3008011247-2021-00041 IS THUS NO LONGER REPORTABLE.

  Patient problems: Failure of Implant

  MAUDE report 11806931 ↗
• InjuryDec 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 1 MONTH POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW-UP A COMPUTED TOMOGRAPHY REVEALED A 3A ENDOLEAK. PATIENT IS REPORTEDLY DOING WELL AND PENDING RE-INTERVENTION.

  Patient problems: Failure of Implant

  MAUDE report 11004328 ↗
• InjuryDec 9, 2020Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE 3B ENDOLEAK AT THE BIFURCATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY EXPLANTING THE DEVICE ON (B)(6) 2020. THE PATIENT IS REPORTEDLY IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 10977887 ↗
• DeathAug 28, 2019Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  THE PATIENT WAS PRESENT WITH AN IMPENDING RUPTURE OF LEFT CIA ANEURYSM AND AN EMERGENCY ENDOVASCULAR ANEURYSM REPAIR WAS PERFORMED. THIS TYPE OF PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF-LABEL). A TYPE 2 ENDOLEAK WAS EMBOLIZED AND A NON- ENDOLOGIX (MEDTRONIC) STENT WAS IMPLANTED IN LEFT COMMON ILIAC ARTERY (LCIA) TO EXTERNAL ILIAC ARTERY EIA. THIS IS ALSO OUTSIDE THE INDICATIONS OF USE (OFF -LABEL) DUE TO CONCOMITANT USE. AFX SHEATH WAS THEN INSERTED FROM THE LEFT ACCESS SITE; HOWEVER, AS THE ORIGIN OF LEFT EIA BECAME NARROWER DUE TO CALCIFICATION, THE AFX SHEATH WAS NOT ABLE TO BE ADVANCED. AS THERE WAS A SEVERE TORTUOSITY CONFIRMED FROM THE RIGHT CIA TO AORTIC BIFURCATION, THE ENTIRE SYSTEM WAS ADVANCED WITH THE STOPPER STILL BEING ATTACHED ON THE DELIVERY SYSTEM. (OFF-LABEL). AFTER UNSHEATHING, BOTH LEG ORIENTATION WAS CROSSED. THE INNER-CORE WAS THEN ROTATED WITH SOME UP AND DOWN MOVEMENTS TO RESOLVE CROSSING LEGS; BUT ITS ORIENTATION WAS NOT CHANGED. THE PHYSICIAN ATTEMPTED TO DEPLOY BIFURCATED STENT GRAFT WITH THIS CROSSING LEGS CONDITION. ALTHOUGH, THE CONTROL-CORD WAS PULLED, THE STENT GRAFT WAS NOT DEPLOYED. IN ORDER TO TRY TO RESOLVE CROSSING LEGS AGAIN, THE PHYSIC

  Patient problems: Death

  MAUDE report 8941872 ↗
• InjuryApr 10, 2019Use 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. IMMEDIATELY POST INITIAL CASE, AN ANGIOGRAM AND CT REVEALED A TYPE IA AND TYPE II ENDOLEAKS. THE PHYSICIAN THEN MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO RESOLVE THE LEAKS, BUT ULTIMATELY DECIDED TO TERMINATE THE PROCEDURE AND MONITOR THE PATIENT, WHO ALSO HAD A HEART ATTACK AFTER THE CASE. FOUR (4) DAYS POST INITIAL TREATMENT, THE PATIENT PASSED AWAY FROM CARDIAC COMPLICATIONS. THE PHYSICIAN COMMENTED THAT THE PATIENT HAD SEVERE CARDIAC PROBLEMS PRIOR TO THE AAA INTERVENTION WITH SEVERAL CORONARY STENTS IMPLANTED. IN ADDITION, AFTER THE PATIENT'S HEART ATTACK, THE CORONARY STENTS BECAME PARTIALLY OCCLUDED, AFTER WHICH THE PATIENT'S CONDITION CONTINUED TO WORSEN EVEN WITH ATTEMPTS TO TREAT.

  Patient problems: Death; Failure of Implant; Heart Failure; Occlusion

  MAUDE report 8501428 ↗
• InjurySep 7, 2018Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  THE PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2018. AN AFX2 BIFURCATED STENT GRAFT AND TWO AXF LIMB STENT GRAFTS WERE IMPLANTED. DURING A FOLLOW-UP VISIT A TYPE IB ENDOLEAK WAS IDENTIFIED. THE PATIENT WAS ASYMPTOMATIC. THE TYPE IB WAS SEALED WITH AN ILIAC EXTENSION ON (B)(6) 2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 7858266 ↗
• DeathMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AFX2 BIFURCATED WAS IMPLANTED TO TREAT A PATIENT WITH A TIGHT DISTAL AORTA. IT WAS REPORTED THAT THE AORTA RUPTURED AND THE PATIENT EXPIRED APPROXIMATELY 36 HOURS POST IMPLANT. THE PHYSICIAN STATED THAT HE DOES NOT BELIEVE THAT THE EVENT IS RELATED TO THE AFX2 STENT GRAFT. IT WAS ALSO NOTED THAT THE PATIENT HAS A HISTORY OF A THORACIC AAA.

  Patient problems: Death; Rupture

  MAUDE report 7520119 ↗

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-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-1035-2017 · Dec 27, 2016 · Terminated
  AFX Endovascular AAA System, Endoleak Type IIIA
• 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-0594-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
• 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-0593-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-0590-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
• 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-0592-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.