AFX2 Bifurcated Endograft System BEA25-70/I16-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00818009014870), received between Jul 8, 2016 and Jul 28, 2025 — classified as 16 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2025Lack of Effect; Lack of Effect

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2021 WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. ROUTINE FOLLOW-UP CONDUCTED ON (B)(6) 2025 IDENTIFIED A TYPE IIIA ENDOLEAK (JUNCTIONAL) DUE TO INADEQUATE OVERLAP BETWEEN THE MAIN BODY AND CUFF. REINTERVENTION WAS COMPLETED ON (B)(6) 2025 BY IMPLANTING AN AFX VELA INFRARENAL BRIDGE TO INCREASE THE OVERLAP IN AN EFFORT TO FIX THE TYPE IIIA ENDOLEAK. HOWEVER, AFTER THE PLACEMENT OF AN AFX VELA INFRARENAL THE TYPE IIIA ENDOLEAK PERSISTED. THE SURGEON THEN OPTED TO RE-LINE WITH A LONGER AFX BIFURCATED STENT GRAFT THE TYPE IIIA ENDOLEAK WAS RESOLVED. THE FINAL PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 22638462 ↗
• InjuryMay 7, 2025Off-Label Use; Material Puncture/Hole; Off-Label Use; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED WITH THORACIC ENDOVASCULAR AORTIC REPAIR FOR A FUSIFORM ANEURYSM WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL. THE AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED THROUGH THE RIGHT APPROACH AND THEN THE VELA SUPRARENAL WAS IMPLANTED RIGHT BELOW THE RENAL ARTERIES. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL 10MM BARE STENT (NON-ENDOLOGIX) BECAUSE THE LEFT COMMON ILIAC ARTERY WAS NARROW. 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 AND THE ABSENCE OF AN ABDOMINAL AORTIC ANEURYSM. THE FINAL ANGIOGRAPHY CONFIRMED THERE WERE NO ENDOLEAKS AND THE PROCEDURE WAS COMPLETED. APPROXIMATELY FOUR AND A HALF (4.5) YEARS POST INITIAL PROCEDURE, THE PATIENT WAS SENT TO THE EMERGENCY ROOM DUE TO AN IMPENDING RUPTURE. AN EMERGENCY OPEN SURGERY WAS PERFORMED, AND 2 BLOOD LEAKS FROM THE SUTURE LINES OF THE FRONT AND BACK SIDE OF THE AFX2 BIFURCATED STENT GRAFT WERE CONFIRMED. THE SUTURE HOLES WERE REPAIRED WITH HYDROFIT (NON-ENDOLOGIX). ANEURYSMORRHAPHY WAS PERFORMED AND THE PROCEDURE WAS COMPLETED. NOTE: THE AFX2 SYSTEM WAS EVALUATED USIN

  Patient problems: Clinical Endoleak

  MAUDE report 21977970 ↗
• InjuryApr 29, 2025Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL AORTIC EXTENSION. APPROXIMATELY FIFTEEN (15) DAYS POST INITIAL PROCEDURE, DURING REVIEW OF A FOLLOW COMPUTED TOMOGRAPHY (CT) SCAN A TYPE 3B ENDOLEAK WAS SUSPECTED. THE PHYSICIAN ELECTED TO PERFORM AN ANGIOGRAM AND BALLOON THE EXISTING IMPLANTED STENT GRAFT FOLLOWED BY IMPLANT OF AN AFX INFRARENAL AORTIC EXTENSION TO RESOLVE THE EVENT.

  Patient problems: Clinical Endoleak; Exsanguination

  MAUDE report 21929157 ↗
• InjuryApr 17, 2025Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT (BSG) AND AN AFX VELA SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON (B)(6) 2019. IT WAS REPORTED THAT FOUR (4) YEARS POST INITIAL PROCEDURE THE CONTRAST-ENHANCED COMPUTED TOMOGRAPHY (CT) SHOWED THAT THERE WAS ANEURYSM ENLARGEMENT, ENLARGING FROM 45.0 MM TO 57.3 MM AND A TYPE IIIA ENDOLEAK (IMPLANT SEPARATION) BETWEEN THE AFX2 BSG AND AFX VELA SUPRARENAL AORTIC EXTENSION. ON (B)(6) 2024, AN AFX VELA SUPRARENAL AORTIC EXTENSION WAS IMPLANTED OVERLAPPING THE AFX2 BSG AND AFX VELA SUPRARENAL AORTIC EXTENSION BY 5 CM EACH. THE INTRAOPERATIVE CONTRAST CONFIRMED THAT THE TYPE IIIA ENDOLEAK WAS RESOLVED. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED ON POSTOPERATIVE DAY FIVE. THE PATIENT STATUS WAS NOT REPORTED.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 21857499 ↗
• InjuryNov 14, 2023Off-Label Use; Lack of Effect; Off-Label Use; Lack of Effect

  THE PATIENT WAS TREATED FOR AN EMERGENCY ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON (B)(6) 2023. SEVERAL GORE (NON-ENDOLOGIX) VIABAHN VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) HAD PREVIOUSLY BEEN IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY (CIA) TO THE EXTERNAL ILIAC ARTERY (EIA). DURING THIS EVAR, AN AFX2 BIFURCATED STENT GRAFT WAS IMPLANTED FROM THE LEFT ACCESS AND AN ADDITIONAL VBX STENT GRAFT WAS ALSO ADDED. (THIS INITIAL PROCEDURE IS OUTSIDE OF THE INDICATIONS OF USE (OFF-LABEL) DUE TO THE USE OF ADJUNCTIVE DEVICES NOT COMPATIBLE WITH THE AFX2 SYSTEM). ON (B)(6) 2023 AN EMERGENCY EVAR WAS PERFORMED DUE TO ANEURYSM RUPTURE. REPORTEDLY, IT WAS POSSIBLY DUE TO TYPE IIIA ENDOLEAK DUE TO THE VBX STENT GRAFT MIGRATION OR A TYPE IIIB ENDOLEAK OF THE AFX2 BIFURCATED STENT GRAFT; HOWEVER, THIS WAS NOT DEFINITIVELY DETERMINED. A MEDTRONIC (NON-ENDOLOGIX) ENDURANT CUFF WAS ADDED AT THE PROXIMAL PORTION, AND A VBX STENT GRAFT WAS ADDED FROM THE RIGHT CIA TO EIA. AN AFX INTRODUCER SHEATH WAS INSERTED AND AN AFX2 BIFURCATED STENT GRAFT DELIVERY SYSTEM WAS DOCKED. SMALL RESISTANCE WAS FELT WHEN DOCKING DEVICES, BUT THE SHEATH VALVE WAS CONFIRMED IN OPEN POSITION. THE PHYSICIAN ATTEM

  Patient problems: Clinical Endoleak; Ruptured Aneurysm

  MAUDE report 18136826 ↗
• InjuryOct 17, 2023Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA INFRARENAL PROXIMAL EXTENSION. APPROXIMATELY ONE AND A HALF (1.5) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED AT THE HOSPITAL AND NOT FEELING WELL (THE SPECIFIC SYMPTOMS ARE UNKNOWN). CT (COMPUTED TOMOGRAPHY) SCAN REVEALED A POSSIBLE TYPE IIIB ENDOLEAK AND "IMPENDING RUPTURE". THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING ONE (1) ADDITIONAL AFX2 BIFURCATED STENT GRAFT AND ONE (1) AFX VELA INFRARENAL ON (B)(6) 2023. REPORTEDLY, THE ENDOLEAK WAS RESOLVED AND THE PATIENT WAS IN STABLE CONDITION POST RE-INTERVENTION.

  Patient problems: Clinical Endoleak

  MAUDE report 17953930 ↗
• InjurySep 1, 2021Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY, 1.5 YEARS POST INITIAL PROCEDURE A ROUTINE FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IDENTIFIED A 3B ENDOLEAK, A 1A ENDOLEAK AND A TYPE 2 ENDOLEAK (NON-DEVICE RELATED). REPORTEDLY, THE PHYSICIAN ELECTED TO TREAT THE 3B ENDOLEAK WITH A NON-ENDOLOGIX STENT GRAFT AND THE 1A ENDOLEAK WITH A NON-ENDOLOGIX (EXCLUDER) STENT. THE PATIENTS CONDITION POST RE-INTERVENTION WAS NOT REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12411614 ↗
• InjuryMay 5, 2021Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND GORE (NON-ENDOLOGIX) EXCLUDER LEGS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA); THIS INITIAL IMPLANT IS OUTSIDE THE INDICATIONS OF USE. APPROXIMATELY (20) TWENTY DAYS POST INITIAL PROCEDURE, IT WAS REPORTED THAT AT AN UNKNOWN DATE THE PATIENT WAS FOUND TO HAVE NECROSIS IN THE LARGE INTESTINE. THE LARGE INTESTINE WAS REMOVED. IT'S POSSIBLE THAT THE NECROSIS OCCURRED BECAUSE THE BLOOD FLOW TO THE AREA WAS BLOCKED DUE TO THE EMBOLIZATION OF BOTH INTERNAL ILIAC ARTERIES AND THE OCCLUSION OF THE INFERIOR MESENTERIC AND LUMBAR ARTERIES WITH THE AFX2 BIFURCATED STENT GRAFT. THE PATIENT WAS DISCHARGED AFTER THE SURGERY TO TREAT THE NECROSIS.

  Patient problems: Ischemia; Necrosis

  MAUDE report 11780268 ↗
• InjuryDec 1, 2020Use of Device Problem; Patient-Device Incompatibility; Insufficient Device Problem Information; Use of Device Problem; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS POST INITIAL IMPLANT, A POSSIBLE TYPE IIIA ENDOLEAK WAS IDENTIFIED DURING ROUTINE FOLLOW-UP. RE-INTERVENTION WAS COMPLETED SUCCESSFULLY WITH IMPLANT OF AN AFX VELA INFRARENAL. ADDITIONALLY, THERE WAS A TYPE II ENDOLEAK (NON-DEVICE RELATED) ON THE FINAL ANGIOGRAM. THE PATIENT WILL BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 10928640 ↗
• InjuryNov 30, 2020Separation Problem; Separation Problem

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH SEVERE ABDOMINAL AND BACK PAIN, AND COLDNESS IN THE LOWER EXTREMITIES. A COMPONENT SEPARATION (CLASSIFIED AS A TYPE IIIA ENDOLEAK) WAS DETECTED. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY AORTOFEMORAL BYPASS SURGERY ON (B)(6) 2020. PATIENT IS REPORTEDLY RECOVERING WELL, BUT THROMBUS IS STILL PRESENT FROM THE MID-AORTA TO THE FEMORAL ARTERIES. IT IS UNKNOWN IF THE PHYSICIAN PLANS TO TREAT THE PATIENT FURTHER. ADDITIONAL INFORMATION: THE REPORTED INTRA-STENT THROMBUS FROM THE RENAL ARTERIES TO THE BILATERAL FEMORAL ARTERIES CAUSED COMPLETE AORTIC OCCLUSION AND THERE WAS SAC GROWTH OF 13MM THAT WAS NOT INCLUDED IN THE EVENT AS REPORTED

  Patient problems: Failure of Implant; Occlusion; Pain; Thrombus

  MAUDE report 10920404 ↗
• InjuryMay 5, 2020Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY TREATED EMERGENTLY WITH ENDOVASCULAR ANEURYSM REPAIR FOR AN AORTODUODENAL FISTULA. THIS INDEX PROCEDURE IS OUTSIDE THE INDICATIONS OF USE DUE TO THE EMERGENT REPAIR AND FOR THE TREATMENT OF AORTODUODENAL FISTULA. AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL WERE IMPLANTED. THE OPERATION WAS COMPLETED WITHOUT AN ENDOLEAK. A PLANNED OPEN SURGERY WAS PERFORMED THE FOLLOWING DAY TO TREAT THE DUODENUM SIDE. THROMBI WERE REMOVED FROM THE ANEURYSM. DURING THIS SURGERY, AN ENDOLEAK WAS OBSERVED FROM THE AFX2 STENT GRAFT EXPOSED FROM THE MISSING PART OF AORTA WALL. THE LEAK WAS SMALL AND WAS SOLVED WITH COMPRESSION. THE PATIENT WAS STABLE POST PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 10027167 ↗
• InjuryDec 22, 2019Misconnection; Use of Device Problem; Malposition of Device; Misconnection; Use of Device Problem; Malposition of Device

  THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE AFX2 ABDOMINAL AORTIC ANEURYSM STENT AND TWO (2) GORE (NON-ENDOLOGIX) EXCLUDER CUFFS (OUTSIDE INDICATIONS OF USE). APPROXIMATELY ONE (1) YEAR POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK WAS CONFIRMED AT THE JUNCTION OF THE BIFURCATED AND INFRARENAL DEVICES. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING A MEDTRONIC (NON-ENDOLOGIX) ENDURANT LIMB ON (B)(6) 2019. AS AN ENDOLEAK WAS STILL SLIGHTLY OBSERVED, THE PHYSICIAN ELECTED TO FURTHER TREAT BY CONVERTING THE PATIENT TO OPEN SURGERY AND SUTURING THE JUNCTION. THE ENDOLEAK WAS CONFIRMED RESOLVED AND THE PATIENT IS REPORTED IN GOOD CONDITION. AS OF DATE, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION RECEIVED PER CLINICAL ASSESSMENT CONFIRMING THAT THE TYPE IIIA ENDOLEAK WAS FIRST EVIDENT ON 06 NOV 2018 PER CT (COMPUTED TOMOGRAPHY) STUDY; DATE OF EVENT HAS BEEN UPDATED. IN ADDITION, PHYSICIAN REPORTED THAT THE INFRARENAL EXTENSION WAS PLACED LOWER THAN INTENDED AT INITIAL IMPLANT PER CT STUDY AT ONE-MONTH POSTOPERATIVE.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9508912 ↗
• InjuryDec 10, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, ANEURYSM ENLARGEMENT WAS IDENTIFIED WITH NO ENDOLEAK CONFIRMED. THE PHYSICIAN ELECTED TO PERFORM OPEN SURGERY AND EXPLANT THE DEVICES. DURING THE OPEN SURGERY, THE PHYSICIAN SUSPECTS A LEAK FROM THE SUTURE HOLES (POSSIBLE 3B ENDOLEAK) OF THE BIFURCATED STENT GRAFT. THE OPEN SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: Aneurysm; Failure of Implant

  MAUDE report 9445728 ↗
• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH FLANK PAIN AND A TYPE 3A ENDOLEAK WAS IDENTIFIED. THE PHYSICIAN IMPLANTED ANOTHER PROXIMAL TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: Failure of Implant

  MAUDE report 9293779 ↗
• MalfunctionSep 1, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING THE INITIAL IMPLANT OF THE AFX DEVICES IT WAS OBSERVED THE IMPLANTED STENT DIMENSIONS DID NOT MATCH THE DIMENSIONS ON THE LABEL OF THE DEVICE. THE PROCEDURE WAS COMPLETED AND IT WAS REPORTED THE PATIENT HAD AN UNKNOWN ENDOLEAK REMAINING AT THE END OF THE PROCEDURE. THE UNKNOWN ENDOLEAK IS ADDRESSED ON AN ADDITIONAL REPORT TO THE FDA. THIS REPORT IS FOR THE POTENTIAL MISLABELING OF THE EVENT DEVICE. THERE HAVE BEEN NO ADDITIONAL ADVERSE EVENTS REPORTED FOR THIS PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6840501 ↗
• InjuryOct 26, 2016Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING PATIENT INITIAL PROCEDURE ON (B)(6) 2016 THE CONTRA-LIMB WIRE BECAME ENTANGLED RESULTING IN AN ENDOKNOT. THE PHYSICIAN WAS ABLE TO RECONCILE THE KNOT WHICH PROLONGED THE PROCEDURE. POST PROCEDURE THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR AN ISCHEMIC LEG AS WELL AS AN OCCLUDED LEFT EXTERNAL ILIAC ARTERY DUE TO A DISSECTION. THE PHYSICIAN COMPLETED A SURGICAL EXPLORATION OF THE LEFT COMMON FEMORAL ARTERY WITH PATCH ANGIOPLASTY AND PLACED STENTS IN THE LEFT COMMON ILIAC ARTERY AS WELL AS THE LEFT EXTERNAL ILIAC ARTERY TO RESOLVE THE DISSECTION AND OCCLUSION. HIS RECOVERY WAS COMPLICATED BY ACUTE ENCEPHALOPATHY WITH CONFUSION AND A MINIMAL LEFT SIDE RETROPERITONEAL HEMATOMA.

  Patient problems: Hematoma; Intimal Dissection; Ischemia; Occlusion; Thrombus

  MAUDE report 6058937 ↗
• InjuryJul 8, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL PROCEDURE ON (B)(6) 2016 WITH A BIFURCATED AND SUPRARENAL AORTIC EXTENSION. SUBSEQUENTLY, ON (B)(6) 2016, THE PATIENT WAS TAKEN TO THE HOSPITAL EMERGENTLY WHERE THE PHYSICIAN DETERMINED THERE WAS COMPLETE GRAFT OCCLUSION. PHYSICIAN ELECTED TO USE A NON-ENDOLOGIX DEVICE TO REPAIR. PATIENT ALSO HAD AN ABOVE KNEE AMPUTATION. PATIENT IS IN STABLE CONDITION.

  Patient problems: Ischemia; Necrosis; Occlusion

  MAUDE report 5779901 ↗

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-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-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-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-0591-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-135BL
• 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-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-0590-06 · 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-0589-06 · Dec 14, 2005 · Terminated
  Powerlink System for Abdominal Aortic Aneurysm (Endoluminal Bifurcated Prosthesis with Delivery System) Model No. 25-16-140BL

…and 1 more.