Flair® Endovascular Stent Graft FAS08050Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04049519008998), received between Nov 12, 2015 and Oct 26, 2020 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (16 reports).

1 other recall cover devices cleared under the same FDA submission (P060002); 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2020Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS08050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD PATIENT INVOLVEMENT, BUT THE PATIENT HAD NO CONSEQUENCES. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10735127 ↗
• MalfunctionJan 30, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN A SEVERELY STENOSED LEFT CEPHALIC ARCH VIA ACCESS THROUGH A LEFT CEPHALIC DIALYSIS FISTULA, THE TIP OF THE DELIVERY CATHETER ALLEGEDLY BROKE AND BECAME STUCK IN THE TREATMENT SITE AFTER DEPLOYMENT OF THE STENT GRAFT . THEREFORE, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8291396 ↗
• MalfunctionSep 4, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING PLACEMENT OF THE VASCULAR STENT GRAFT IN THE LOOP GRAFT, THE STENT GRAFT ALLEGEDLY DEPLOYED IN AN UNINTENDED PLACEMENT SITE. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT, AND A SECOND ENDOVASCULAR STENT GRAFT WAS DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7844058 ↗
• MalfunctionAug 28, 2018Material Puncture/Hole; Material Separation; Activation, Positioning or Separation Problem; Material Puncture/Hole; Material Separation; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE CEPHALIC FISTULA, THE STENT GRAFT WAS ALLEGEDLY PARTIALLY DEPLOY. IT WAS REPORTED EXCESSIVE FORCE WAS APPLIED TO DEPLOY THE STENT GRAFT. IT WAS FURTHER REPORTED THAT HALF OF THE STENT WAS ALLEGEDLY STUCK INTO THE SHEATH AND THE OTHER HALF WAS STICKING OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7825334 ↗
• MalfunctionFeb 27, 2018Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT IN A FOREARM AV GRAFT FISTULA, THE DELIVERY SYSTEM ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. REPORTEDLY, THE DELIVERY SYSTEM AND INTRODUCER SHEATH WERE REMOVED TOGETHER AS A SINGLE UNIT AND ANOTHER STENT GRAFT DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7299668 ↗
• MalfunctionOct 5, 2017Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY IN THE CEPHALIC VEIN VIA THE FISTULA; THEREFORE, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6918579 ↗
• MalfunctionAug 31, 2017Break; Fracture; Activation, Positioning or Separation Problem; Break; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE TO TREAT A LOOP GRAFT AND STENOSIS, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED AND BROKE. THE HEALTH CARE PROVIDER REMOVED THE DELIVERY SYSTEM WITHOUT LOSING GUIDEWIRE ACCESS TO THE TREATMENT SITE. ANOTHER DEVICE AND AN INTRODUCER SHEATH WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6835426 ↗
• MalfunctionJul 24, 2017Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED FROM THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM; THEREFORE, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6737044 ↗
• MalfunctionNov 30, 2016Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM DURING TREATMENT IN A GRAFT VENOUS ANASTOMOSIS. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE DELIVERY SYSTEM THROUGH THE SHEATH. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6135104 ↗
• MalfunctionJun 23, 2016Break; Break

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT IN THE ARTERIAL LIMB OF A GRAFT, THE HCP ENCOUNTERED SLIGHT RESISTANCE AND THE OUTER CATHETER OF THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM ALLEGEDLY BROKE. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. REPORTEDLY, THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5746809 ↗
• MalfunctionMar 24, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT AN ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY IN A BRACHIOCEPHALIC FISTULA. THERE WERE NO REPORTED RETRACTION DIFFICULTIES. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5525111 ↗
• MalfunctionJan 8, 2016Break; Break; Detachment Of Device Component

  IT WAS REPORTED THAT UPON A SUCCESSFUL DEPLOYMENT OF A STENT GRAFT, THE CATHETER DETACHED NEAR THE HANDLE DURING REMOVAL. THE ENTIRE DEPLOYMENT SYSTEM WAS REMOVED WITHOUT INCIDENT. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5354840 ↗
• MalfunctionJan 8, 2016Break; Break; Crack

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT IN AN AV GRAFT, WHILE ADVANCING THE DEPLOYMENT SYSTEM THROUGH THE TORTUROUS GRAFT THE OUTER CATHETER CRACKED NEAR THE DEPLOYMENT HANDLE. THE STENT GRAFT WAS EXCHANGED OVER THE GUIDE WIRE FOR A COVERED STENT THAT WAS DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5354839 ↗
• MalfunctionJan 8, 2016Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE, UPON DEPLOYMENT THE OUTER SHEATH BROKE AS THE STENT GRAFT COULD NOT BE DEPLOYED; THEREFORE, THE STENT GRAFT WAS EXCHANGED OVER THE GUIDE WIRE FOR NEW STENT GRAFT THAT WAS PREPPED AND DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5354773 ↗
• MalfunctionJan 8, 2016Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN AN A-V FISTULA, THE OUTER CATHETER BROKE AND THE STENT GRAFT WOULD NOT DEPLOY. THE ENTIRE DEPLOYMENT SYSTEM WAS REMOVED AND ANOTHER STENT GRAFT WAS SUCCESSFULLY DEPLOYED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5354757 ↗
• MalfunctionJan 8, 2016Positioning Failure; Activation, Positioning or Separation Problem; Break; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT AT THE ANASTOMOSIS OF A BASILIC VEIN A-V GRAFT, THE OUTER CATHETER BROKE NEAR THE HANDLE AND THE STENT GRAFT COULD NO LONGER BE DEPLOYED. THE STENT GRAFT DEPLOYMENT WAS ABLE TO BE COMPLETED BY MANUAL RETRACTION OF THE OUTER CATHETER. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5354691 ↗
• MalfunctionJan 8, 2016Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE IN AN AV GRAFT, THE STENT GRAFT COULD NOT BE DEPLOYED; THEREFORE, IT WAS EXCHANGED OVER THE GUIDE WIRE FOR A NEW STENT GRAFT THAT WAS ADVANCED TO THE LESION SITE; HOWEVER, THE STENT GRAFT COULD NOT BE DEPLOYED. THE STENT GRAFT WAS EXCHANGED OVER THE GUIDE WIRE FOR ANOTHER STENT GRAFT THAT WAS PREPPED AND DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5354660 ↗
• MalfunctionJan 8, 2016Break; Break; Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE OF AN AV GRAFT, THE STENT GRAFT WAS DIFFICULT TO DEPLOY; HOWEVER, THE STENT GRAFT WAS DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5354523 ↗
• MalfunctionJan 7, 2016Break; Break; Positioning Failure

  IT WAS REPORTED THAT THE STENT GRAFT COULD NOT BE DEPLOYED AFTER BEING POSITIONED AT A TIGHT BEND IN AN A-V GRAFT. SEVERAL ATTEMPTS WERE MADE TO DEPLOY THE STENT GRAFT UNTIL THE OUTER SHEATH BROKE. THE ENTIRE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5352482 ↗
• MalfunctionJan 7, 2016Break; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT IN AN A-V LOOP GRAFT OF THE FOREARM, THE STENT GRAFT COULD NOT BE DEPLOYED. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO DEPLOY THE STENT GRAFT, THE ENTIRE DEVICE WAS REMOVED AND A NEW STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5352450 ↗
• MalfunctionJan 7, 2016Activation Failure; Device Operates Differently Than Expected; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT IN THE BRACHIAL VEIN, THE FLARED END OF THE STENT GRAFT DID NOT COMPLETELY OPEN. NO FURTHER INTERVENTION WAS PERFORMED. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5352391 ↗
• MalfunctionNov 25, 2015Break; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY IN THE PROXIMAL LOWER LEFT ARM GRAFT. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE VESSEL AND A PREVIOUSLY PLACED STENT GRAFT. REPORTEDLY, ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5251726 ↗
• MalfunctionNov 12, 2015Break; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT FULLY DEPLOY IN THE PROXIMAL LOWER LEFT ARM GRAFT. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE VESSEL AND A PREVIOUSLY PLACED STENT GRAFT. REPORTEDLY, ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5220532 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060002. One submission often covers many models, so check the product and lot details in each record.

• Z-0223-2016 · Oct 19, 2015 · Terminated
  FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis c