AFX Endovascular AAA System BA28-80/I16-40Recalls & reported problems
Endologix LLC · Class 3 · Implant
All models of AFX Endovascular AAA System (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00818009010025), received between Jun 16, 2016 and Dec 10, 2024 — classified as 20 injuries.
The most frequently reported specific device problem is “Leak/Splash” (9 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash9
- Adverse Event Without Identified Device or Use Problem6
- Failure To Adhere Or Bond4
- Insufficient Device Problem Information3
- Material Puncture/Hole3
- Hole In Material2
- Material Integrity Problem2
- Off-Label Use2
Patient problems
- Failure of Implant14
- Aneurysm7
- No Information4
- Clinical Endoleak2
- Pain2
- Rupture2
- Blood Loss1
- Death1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Off-Label Use; Device-Device Incompatibility; Separation Problem; Off-Label Use; Device-Device Incompatibility; Separation Problem
THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT A FUSIFORM SHAPED ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY EIGHT (8) YEARS POST INITIAL PROCEDURE, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN SHOWED JUNCTION SEPARATION BETWEEN THE AFX2 BIFURCATED STENT GRAFT AND THE VELA AORTIC EXTENSION AND THERE WAS A TYPE 3A ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN AFX AORTIC EXTENSION BETWEEN THE EXISTING STENT GRAFTS ON (B)(6) 2024. THE FINAL ANGIOGRAM SHOWED THAT THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PROCEDURE WAS COMPLETED. THE PATIENT STATUS WAS NOT REPORTED.
Patient problems: Clinical Endoleak
MAUDE report 20891972 ↗InjuryJun 10, 2024Separation Problem; Lack of Effect; Separation Problem; Lack of Effect
THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. APPROXIMATELY EIGHT AND A HALF (8.5) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS BROUGHT IN FOR AN AORTA GRAM FOR EXPLORATION OF AN ENDOLEAK AS THE PATIENT WAS KNOW TO HAVE AN EXPANDING ANEURYSM ENLARGEMENT. THE ENDOLEAK WAS SUSPECTED TO BE A TYPE 2 AND THE PATIENT WAS COMPLETELY ASYMPTOMATIC. DURING THE AORTA GRAM, IT WAS DETERMINED THAT THE ENDOLEAK WAS A TYPE 3A RATHER THAN A TYPE 2. AT THIS POINT, THE PHYSICIAN ELECTED TO RELINE THE ORIGINAL IMPLANTED DEVICES WITH AN AFX2 BIFURCATED STENT GRAFT. ACCESS WAS OBTAINED AND EVERYTHING LOOKED GOOD AND THE PHYSICIAN TRIED TO ASSURE THE DEVICE WAS CENTERED. THE AFX2 BIFURCATED DEVICE WAS INSERTED INTO THE SHEATH; HOWEVER, AS THE DEVICE WAS BEING POSITIONED, IT BECAME APPARENT THAT THE AFX2 LIMB WAS BEHIND A STENT. THE PHYSICIAN ELECTED TO REMOVE THE AFX2 DEVICE AND SHEATH AND COMPLETED THE PROCEDURE WITH ANOTHER AFX2 BIFURCATED DEVICE AND SUPRARENAL AORTIC EXTENSION. THE ENDOLEAK WAS RESOLVED AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. THE PATIENT WAS REPORTED AS DID VERY
Patient problems: Aneurysm; Clinical Endoleak
MAUDE report 19503276 ↗InjurySep 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS INITIALLY TREATED FOR A ABDOMINAL AORTIC ANEURYSM (AAA) WITH AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. APPROXIMATELY FIVE (5) YEARS POST INITIAL PROCEDURE THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH ABDOMINAL AND BACK PAIN. A TYPE IIIA ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICES. REPORTEDLY, THE PATIENT DID WELL.
Patient problems: Failure of Implant
MAUDE report 12457485 ↗InjurySep 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (5) FIVE YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WAS IDENTIFIED DURING A ROUTINE FOLLOW-UP. THE PATIENT WAS EXPERIENCING ABDOMINAL AND BACK PAIN. THE PHYSICIAN ELECTED TO PERFORM A RE-INTERVENTION AND IMPLANTED AN AFX VELA SUPRARENAL. THE ENDOLEAK WAS SUCCESSFULLY SEALED AND THE PATIENT WAS DISCHARGED POST OPERATIVE DAY ONE (1). SUBSEQUENT TO THE INITIAL REPORT, CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO REASONABLY SUGGEST SAC GROWTH OF 22MM OCCURRED THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED. THE SAC GROWTH WAS DISCOVERED DURING A REVIEW OF THE MEDICAL RECORDS.
Patient problems: Aneurysm; Failure of Implant; Pain
MAUDE report 12415000 ↗InjuryDec 21, 2020Migration; Migration
THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL IMPLANT, DURING ROUTINE FOLLOW-UP THE COMPUTED TOMOGRAPHY SCAN IDENTIFIED CAUDAL MIGRATION OF THE PROXIMAL AFX DEVICE > 10MM. NO FURTHER INFORMATION PROVIDED. PATIENT STATUS WAS NOT REPORTED.
Patient problems: Failure of Implant
MAUDE report 11051704 ↗InjuryNov 13, 2020Material Puncture/Hole; Material Puncture/Hole
THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE DURING A ROUTINE FOLLOW UP, A TYPE 3B ENDOLEAK, DILATION OF THE PROXIMAL EXTENSION, AND AN EXPANDING ANEURYSM WERE IDENTIFIED. THE PHYSICIAN COMPLETED A SUCCESSFUL REINTERVENTION AND RE-LINED THE EXISTING STENT GRAFTS WITH AN AFX2 BIFURCATED STENT GRAFT AND A VELA SUPRARENAL STENT GRAFT EXTENSION. THE ENDOLEAK WAS RESOLVED AND THE PATIENT REPORTEDLY IS DOING VERY WELL AND WENT HOME THE FOLLOWING DAY.
Patient problems: Aneurysm; Failure of Implant
MAUDE report 10838046 ↗InjuryApr 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND AN INFRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). SIX (6) DAYS POST INITIAL PROCEDURE, A SECONDARY PROCEDURE WAS COMPLETED FOR UNKNOWN REASON. ANOTHER INFRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFTS WERE IMPLANTED. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE REGARDING THIS INTERVENTION. ADDITIONAL INFORMATION: THE REPORTED SECONDARY PROCEDURE WAS DUE TO A TYPE 1 ENDOLEAK OF INDETERMINATE ORIGIN.
Patient problems: No Information
MAUDE report 8525449 ↗InjuryNov 9, 2018Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS INITIALLY IMPLANTED WITH A AFX BIFURCATED STENT GRAFT, AN INFRARENAL EXTENSION, AND SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY TWO (2) YEARS POST INITIAL IMPLANT, AN INDETERMINATE ENDOLEAK WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.
Patient problems: Failure of Implant
MAUDE report 8057750 ↗InjuryOct 4, 2018Leak/Splash; Material Puncture/Hole; Material Integrity Problem; Leak/Splash; Material Puncture/Hole; Material Integrity Problem
PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM IN 2014. ON (B)(6) 2018, ENDOLOGIX WAS MADE AWARE OF A TYPE 3B ENDOLEAK OF THE MAIN BODY AND MIGRATION OF CUFF WITH NO LEAK NOTED (REPORTED IN A SEPARATED REPORT) AND SAC GROWTH. ON (B)(6) 2018, THE PATIENT UNDERWENT A SECONDARY WHERE THE PHYSICIAN RELINE THE ORIGINAL IMPLANT WITH ANOTHER BIFURCATED STENT GRAFT AND INFRARENAL STENT GRAFT EXTENSION TO RESOLVE THE LEAK AND MIGRATION ISSUE. THE PATIENT WAS REPORTED AS DOING WELL POST-SECONDARY; THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.
Patient problems: Aneurysm; Failure of Implant
MAUDE report 7936143 ↗InjuryJun 22, 2018Leak/Splash; Patient-Device Incompatibility; Material Integrity Problem; Leak/Splash; Patient-Device Incompatibility; Material Integrity Problem
PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED AND LIMB STENT IN 2014. RECENTLY, DURING A FOLLOW UP SCAN THE PHYSICIAN NOTED S CALCIFIED SHELF N THE LEFT SIDE AND POSTERIOR ASPECT OF THE AORTA WITH AN INDETERMINATE ENDOLEAK. THEY PHYSICIAN PLANS TO RELINE THE PATIENT BUT A DATE HAS NOT BEEN SCHEDULED. THE PATIENT IS CURRENTLY ASYMPTOMATIC. AS OF THIS REPORT, THERE HAS BEEN NO ADDITIONAL PATIENT SEQUALAE REPORTED.
Patient problems: Failure of Implant
MAUDE report 7631779 ↗InjuryJun 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH A AFX BIFURCATED STENT GRAFT AND A AFX AORTIC EXTENSION. SECONDARY PROCEDURE WAS PERFORMED ON (B)(6) 2018, FOR AN UNKNOWN REASON. AN AFX2 MAIN BODY AND TWO ADDITIONAL AFX AORTIC EXTENSIONS WERE IMPLANTED IN THE PATIENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Patient problems: No Information
MAUDE report 7564744 ↗InjuryApr 27, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash
ON (B)(6) 2015, THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT . APPROXIMATELY 1.5 YEARS LATER THERE WAS A CT SCAN PERFORMED IN (B)(6) 2016 SHOWING AN ECTATIC ILIAC THAT GREW TO A TREATABLE SIZE (4CM); A BELLBOTTOM LIMB WAS PLACED ORIGINALLY AND THEN BECAME UNDERSIZED TO THE ILIAC .ON (B)(6) 2017, A SECONDARY PROCEDURE) WAS PERFORMED ;DURING THE INTERVENTION, AN ADDITIONAL LIMB STENT GRAFT WAS IMPLANTED. THE PROCEDURE WAS DONE BY PLACING A 20-13-88 LIMB EXTENSION AND THE OP NOTE SAYS THAT A COMPLETION ANGIOGRAM WAS PERFORMED SHOWING NO TYPE 1 OR TYPE 3 ENDOLEAK. NO PATIENT SEQUELEA HAS BEEN REPORTED.
Patient problems: Aneurysm; Failure of Implant
MAUDE report 7470206 ↗InjuryApr 27, 2018Failure To Adhere Or Bond; Leak/Splash; Failure To Adhere Or Bond; Leak/Splash
ON (B)(6) 2014, A PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM . APPROXIMATELY , 1.5 YEARS LATER , A TYPE 3A LEAK WAS IDENTIFIED IN THE PATIENT DURING AN ANGIOGRAM BY DR. (B)(6) BETWEEN THE MAIN BODY LIMB AND THE LIMB EXTENSION. A SECONDARY PROCEDURE WAS PERFORMED ON (B)(6) 2016. DURING THE INTERVENTION , ONE 25-95 PROXIMAL EXTENSION (USED AS A LIMB EXTENSION) WAS USED TO FIX THE LEAK. NO ADDITIONAL PATIENT SEQUELAE REPORTED.
Patient problems: Aneurysm; Failure of Implant
MAUDE report 7469397 ↗InjuryApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, VELA INFRARENAL, AND TWO (2) LIMB STENT GRAFTS ON (B)(6) 2016. A SECONDARY PROCEDURE WAS PERFORMED FOR THIS PATIENT ON (B)(6) 2017 FOR AN UNKNOWN REASON AND THE PHYSICIAN IMPLANTED AN AFX2 BIFURCATED STENT GRAFT AND NEW VELA INFRARENAL.
Patient problems: No Information
MAUDE report 7445070 ↗InjuryApr 19, 2018Loss of or Failure to Bond; Leak/Splash; Off-Label Use; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Leak/Splash; Off-Label Use; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND VELA SUPRARENAL ON 13 JAN 2015. THE SECONDARY CASE FOR THIS PATIENT WAS COMPLETED ON 05 JAN 2016 FOR AN UNKNOWN REASON AND THE PATIENT WAS IMPLANTED WITH AN AFX VELA SUPRARENAL.
Patient problems: Failure of Implant; No Information
MAUDE report 7444255 ↗InjuryMar 8, 2018Hole In Material; Leak/Splash; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Hole In Material; Leak/Splash; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED AND VELA SUPRARENAL DEVICE IN 2016. DURING A ROUTINE FOLLOW UP, THE PHYSICIAN NOTED A POTENTIAL ENDOLEAK TYPE IIIB WITH FABRIC BILLOWING. PATIENT IS REPORTED AS BEING FINE AND IS CURRENTLY BEING MONITORED.
Patient problems: Failure of Implant; Not Applicable
MAUDE report 7324535 ↗InjuryAug 15, 2017Failure To Adhere Or Bond; Leak/Splash; Stretched; Detachment of Device or Device Component; Failure To Adhere Or Bond; Leak/Splash; Stretched; Detachment of Device or Device Component
THE PATIENT WAS INITIALLY IMPLANTED WITH AFX BIFURCATED AND SUPRARENAL CUFF ON (B)(6) 2014. PATIENT WAS PRESENTED EMERGENTLY WITH RETROPERITONEAL BLEEDING AND A CONTAINED RUPTURE. A CT SCAN WAS COMPLETED JUST PRIOR TO THE SECONDARY PROCEDURE SHOWING EVIDENCE OF A TYPE IIIA ENDOLEAK. THE SECONDARY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017 BY RELINING WITH A GORE TAG PROXIMAL CUFF. THE PATIENT WAS DISCHARGED AND REPORTED AS DOING WELL POST SECONDARY PROCEDURE.
Patient problems: Blood Loss; Failure of Implant; Pain; Rupture
MAUDE report 6796116 ↗InjuryApr 6, 2017Hole In Material; Leak/Splash; Stretched; Hole In Material; Leak/Splash; Stretched
IT WAS REPORTED THE PATIENT HAD AN INITIAL IMPLANT WITH A BIFURCATED STENT AND A SUPRARENAL AORTIC EXTENSION. THE PATIENT CAME IN EMERGENTLY WITH A RUPTURED ANEURYSM. THE PHYSICIAN IDENTIFIED ANEURYSM SAC GROWTH AND A POTENTIAL TYPE 3B OR TYPE 2 ENDOLEAK. IT WAS REPORTED THE PATIENT EXPIRED, THE DATE IS UNKNOWN. A SECONDARY INTERVENTION WAS NOT REPORTED AND IT IS UNKNOWN IF THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE PRIOR TO PASSING AWAY.
Patient problems: Aneurysm; Death; Failure of Implant; Intimal Dissection; Rupture; Thrombus
MAUDE report 6463698 ↗InjurySep 28, 2016Failure To Adhere Or Bond; Adverse Event Without Identified Device or Use Problem; Unintended Movement; Failure To Adhere Or Bond; Adverse Event Without Identified Device or Use Problem; Unintended Movement
PATIENT INITIALLY IMPLANTED WITH A BIFURCATED STENT ON (B)(6) 2014, THE PATIENT HAD SEVERAL NON-ENDOLOGIX STENTS PLACED PROXIMALLY TO THE MAIN BODY. A ROUTINE FOLLOW UP SHOWED A POTENTIAL SEPARATION OF COMPONENTS. A PRELIMINARY CLINICAL REVIEW IDENTIFIED A DECREASE IN OVERLAP BETWEEN THE MAIN BODY AND PROXIMAL EXTENSION, A COMPLETE COMPONENT SEPARATION WAS NOT OBSERVED. DURING THE SAME REVIEW TWO ADDITIONAL NON-ENDOLOGIX STENTS WERE IDENTIFIED IN THE RIGHT AND LEFT ILIACS. THE PATIENT HAS NOT BEEN SCHEDULED FOR A SECONDARY PROCEDURE AND IS IN STABLE CONDITION.
Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient
MAUDE report 5984628 ↗InjuryJun 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT INITIALLY IMPLANTED WITH A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION ON (B)(6) 2016. PHYSICIAN ELECTED NOT TO PLACE A LIMB EXTENSION DURING THE INITIAL PROCEDURE DUE TO THE TORTUOSITY OF THE PATIENTS LEFT COMMON ILIAC. PATIENT CAME IN FOR A FOLLOW UP ON (B)(6) 2016 AN BASED ON COMPUTED TOMOGRAPHY (CT) THE PHYSICIAN ELECTED TO IMPLANT THE LIMB EXTENSION. THE CT DID NOT REVEAL ANY ISSUES WITH THE INITIALLY IMPLANTED DEVICES. THE PATIENT IS IN STABLE CONDITION.
Patient problems: No Code Available
MAUDE report 5729467 ↗
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 · TerminatedAFX2 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 · TerminatedAFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C
- Z-1035-2017 · Dec 27, 2016 · TerminatedAFX Endovascular AAA System, Endoleak Type IIIA
- Z-1037-2017 · Dec 27, 2016 · TerminatedAFX 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 · TerminatedAFX 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 · TerminatedAFX 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 · TerminatedAFX 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 · TerminatedAFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
- Z-0595-06 · Dec 14, 2005 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-140BL
- Z-0594-06 · Dec 14, 2005 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-135BL
- Z-0591-06 · Dec 14, 2005 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
- Z-0590-06 · Dec 14, 2005 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-155BL
- Z-0589-06 · Dec 14, 2005 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
- Z-0596-06 · Dec 14, 2005 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 28-16-155BL
- Z-0592-06 · Dec 14, 2005 · TerminatedPowerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL
…and 1 more.
Other System, Endovascular Graft, Aortic Aneurysm Treatment devices
- Endurant® IIs ESBF2814C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls34 deaths254 reports
- Endurant® IIs ESBF3214C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls19 deaths173 reports
- Endurant® IIs ESBF3614C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT1 recall37 deaths214 reports
- Endurant® IIs ESBF2514C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls18 deaths136 reports
- Endurant® IIs ESBF2314C103EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls9 deaths60 reports
- RelayPro Thoracic Stent-Graft System 28-N4-34-154-34UBolton Medical Inc. · System, Endovascular Graft, Aortic Aneurysm Treatment3 recalls7 reports
- Vela Proximal Endograft System A34-34/C100-O20 VEndologix LLC · System, Endovascular Graft, Aortic Aneurysm Treatment3 deaths152 reports
- Endurant® II ETCF2828C49EMedtronic, Inc. · SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT2 recalls7 deaths44 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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