Flair® Endovascular Stent Graft FAS08070Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 04049519009001), received between Nov 10, 2015 and Nov 11, 2015 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (21 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE THE STENT GRAFT WAS UNABLE TO BE DEPLOYED. THE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5219194 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN A FOREARM LOOP GRAFT, THE DEPLOYMENT SYSTEM SNAPPED AND THE OUTER CATHETER BROKE. THE ENTIRE SYSTEM WAS REMOVED AND A DIALYSIS CATHETER WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218863 ↗
• MalfunctionNov 11, 2015Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON SUCCESSFUL DEPLOYMENT OF A STENT GRAFT IN AN AV GRAFT, THE DELIVERY SYSTEM BROKE OFF AT THE DISTAL END OF THE CATHETER. THE ENTIRE DEVICE WAS REMOVED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 5218860 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE IN AN A-V FISTULA AT THE VENOUS ANASTOMOSIS, THE STENT GRAFT WAS UNABLE TO BE DEPLOYED. THE ENTIRE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218612 ↗
• MalfunctionNov 11, 2015Break

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE IN AN AV GRAFT, UPON DEPLOYMENT THE OUTER CATHETER NEAR THE DEPLOYMENT HANDLE BECAME DETACHED; HOWEVER, THE STENT GRAFT WAS ABLE TO BE DEPLOYED SUCCESSFULLY. THE DEPLOYMENT SYSTEM WAS REMOVED AS ONE UNIT WITHOUT FURTHER INCIDENT. THERE'S NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218379 ↗
• MalfunctionNov 11, 2015Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN THE AXILLARY VEIN, RESISTANCE WAS ENCOUNTERED DURING RETRACTION OF THE SHEATH AFTER THE STENT GRAFT HAD BEEN PARTIALLY RELEASED. ADDITIONAL FORCE WAS APPLIED TO COMPLETE THE DEPLOYMENT OF THE STENT GRAFT SUCCESSFULLY; HOWEVER, THE OUTER CATHETER WAS STRETCHED DURING THE DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218152 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT A STENT GRAFT COULD NOT BE DEPLOYED AS THE DEPLOYMENT MECHANISM WAS UNRESPONSIVE. THE STENT GRAFT WAS EXCHANGED FOR A NEW STENT GRAFT THAT WAS DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218133 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT A STENT GRAFT WOULD NOT DEPLOY AT THE VENOUS ANASTOMOSIS OF AN A-V GRAFT. THE DEVICE WAS RETRACTED WITHOUT INCIDENT. ANOTHER STENT GRAFT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218131 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN AN A BRACHIAL VEIN AV FISTULA, THE OUTER CATHETER BROKE AND COULD NOT BE DEPLOYED. THE DEPLOYMENT SYSTEM WAS REMOVED AND ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218104 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE, THE PROXIMAL END OF THE DEPLOYMENT SHEATH WAS DISCOVERED TO BE BENT AND COULD NOT DEPLOY THE STENT GRAFT; THEREFORE, THE STENT GRAFT WAS EXCHANGED OVER THE GUIDE WIRE FOR A NEW STENT GRAFT THAT WAS PREPPED AND DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218103 ↗
• MalfunctionNov 11, 2015Break

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN AN AV FISTULA, THE OUTER SHEATH THE STENT GRAFT BROKE PRIOR TO DEPLOYMENT; 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

  MAUDE report 5218101 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE FOR AN ARTERIAL ANEURYSM IN A SFA, THE STENT GRAFT WAS UNABLE TO BE DEPLOYED; THEREFORE, THE STENT GRAFT WAS EXCHANGED OVER THE GUIDE WIRE FOR A NEW STENT GRAFT THAT WAS PREPPED AND DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218097 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING A PROCEDURE IN AN A-V FISTULA AT THE VENOUS ANASTOMOSIS, THE STENT GRAFT WAS UNABLE TO BE DEPLOYED. THE ENTIRE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218061 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN AN UPPER ARM GRAFT TO TREAT A THROMBECTOMY, THE STENT GRAFT COULD NOT BE DEPLOYED. THE LESION WAS ADEQUATELY TREATED AND THERE WERE NO ATTEMPTS TO DEPLOYED ANOTHER STENT GRAFT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218051 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING THE ATTEMPT TO PLACE A STENT GRAFT IN AN AXILLLARY VEIN STENOSIS VIA A FOREARM LOOP A-V GRAFT, THE STENT GRAFT COULD NOT BE DEPLOYED AND ADDITIONAL FORCE WAS USED UNTIL THE DELIVERY HANDLE BROKE. THE STENT GRAFT SYSTEM WAS REMOVED IN ITS ENTIRETY AND A NEW STENT GRAFT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218015 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT A STENT GRAFT COULD NOT BE DEPLOYED IN AN UPPER ARM FISTULA. THE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218014 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING THE ATTEMPT TO PLACE A STENT GRAFT IN AN AXILLARY VEIN STENOSIS VIA A FOREARM LOOP A-V GRAFT, THE STENT GRAFT COULD NOT BE DEPLOYED AND ADDITIONAL FORCE WAS USED UNTIL THE DELIVERY HANDLE BROKE. THE STENT GRAFT SYSTEM WAS REMOVED IN ITS ENTIRETY AND A NEW STENT GRAFT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218005 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT A STENT GRAFT COULD NOT BE DEPLOYED IN AN UPPER ARM FISTULA. THE ENTIRE SYSTEM WAS REMOVED AND ANOTHER STENT GRAFT WAS DEPLOYED SUCCESSFULLY WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217823 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED DURING DEPLOYMENT OF A STENT GRAFT TO TREAT THE VENOUS OUTFLOW OF AN A-V FISTULA, RESISTANCE WAS ENCOUNTERED AND THE STENT GRAFT WOULD NOT DEPLOY. THE STENT GRAFT SYSTEM WAS REMOVED WITHOUT INCIDENT AND ANOTHER STENT GRAFT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217796 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT AN ATTEMPT TO PLACE A STENT GRAFT, DEPLOYMENT ISSUES WERE ENCOUNTERED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217790 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT A VASCULAR STENT GRAFT COULD NOT BE DEPLOYED. FOLLOWING SEVERAL UNSUCCESSFUL DEPLOYMENT ATTEMPTS THE STENT GRAFT WAS EXCHANGED FOR NEW STENT GRAFT THAT WAS DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217524 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT A STENT GRAFT COULD NOT BE DEPLOYED IN A BASILIC VEIN A-V GRAFT. THE STENT GRAFT WAS REMOVED AND EXCHANGED OVER THE GUIDE WIRE FOR A PTA BALLOON, AND ANGIOPLASTY WAS PERFORMED SUCCESSFULLY. NO OTHER ATTEMPTS TO DEPLOY A STENT GRAFT WERE MADE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217484 ↗
• MalfunctionNov 11, 2015Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE IN AN AV GRAFT, ADDITIONAL FORCE WAS NEEDED TO COMPLETE THE DEPLOYMENT OF THE STENT GRAFT SUCCESSFULLY. AN ADDITIONAL STENT GRAFT WAS POSITIONED AT THE LESION SITE; HOWEVER, THE STENT GRAFT COULD NOT BE DEPLOYED, ADDITIONAL MANIPULATION WAS UNSUCCESSFUL FOR DEPLOYMENT OF THE STENT GRAFT. THE STENT GRAFT WAS REMOVED OVER THE WIRE. NO ADDITIONAL STENT GRAFTS WERE DEPLOYED. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217321 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE IN THE AXILLARY VEIN, THE STENT GRAFT COULD NOT BE DEPLOYED AT THE LESION SITE. 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

  MAUDE report 5217228 ↗
• MalfunctionNov 11, 2015Device-Device Incompatibility

  IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT PASS THROUGH THE STENT GRAFT DELIVERY SYSTEM PRIOR TO ADVANCEMENT IN THE PATIENT; THEREFORE, THE STENT GRAFT WAS EXCHANGED FOR A NEW STENT GRAFT THAT WAS PREPPED AND DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5217200 ↗

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