Flair® Endovascular Stent Graft FAF07050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04049519008790), received between Feb 19, 2016 and Jul 16, 2020 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 16, 2020Break; Retraction Problem; Break; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAF07050 FLAIR ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD PATIENT INVOLVEMENT BUT THE PATIENT HAD NO CONSEQUENCES. THE PATIENT'S AGE AND WEIGHT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286808 ↗
• MalfunctionJul 9, 2018Break; Positioning Failure; Retraction Problem; Material Deformation; Break; Positioning Failure; Retraction Problem; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT WAS ALLEGEDLY MET WITH SOME RESISTANCE DURING DEPLOYMENT ATTEMPT AND THE DELIVERY CATHETER ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE STENT GRAFT ALLEGEDLY DID NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7672245 ↗
• MalfunctionMay 31, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A SHUNTOGRAM STENT GRAFT PLACEMENT OF THE UPPER ARM, THE STENT GRAFT ALLEGEDLY COULD NOT BE FULLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM AND STENT GRAFT WERE REMOVED FROM THE SHEATH WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7558997 ↗
• MalfunctionMay 31, 2018Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A SHUNTOGRAM STENT GRAFT PLACEMENT OF THE UPPER ARM, THE HUB OF THE DELIVERY SYSTEM ALLEGEDLY BROKE. THE DEVICE WAS REMOVED FROM THE SHEATH WITHOUT ISSUES AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7558996 ↗
• MalfunctionJan 8, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING STENT GRAFT DEPLOYMENT INTENDED FOR THE STENOSIS IN THE VENOUS ANASTOMOSIS OF THE HEMODIALYSIS GRAFT OF THE UPPER ARM, THE STENT GRAFT ALLEGEDLY JUMPED AND MOVED INTO THE BASILIC VEIN. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED AND THERE WERE NO DIFFICULTIES ADVANCING OR RETRACTING THE DELIVERY SYSTEM. IN ADDITION, EXCESSIVE FORCE WAS NOT USED DURING STENT GRAFT DEPLOYMENT. AFTER MULTIPLE FAILED ATTEMPTS WERE MADE TO PULL DOWN THE STENT GRAFT, IT WAS ABLE TO BE PULLED DOWN WITH A BALLOON AND ANOTHER DEVICE WAS USED TO PIN THE STENT GRAFT TO THE VESSEL. THE PROCEDURE WAS COMPLETED USING THE SAME ACCESS SITE AND NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7173627 ↗
• MalfunctionNov 30, 2017Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY JUMPED FORWARD WHILE REMOVING THE OUTER SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7073277 ↗
• MalfunctionJul 10, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ATTEMPT TO DEPLOY THE ENDOVASCULAR STENT GRAFT IN THE ACUTE ANGLE OF THE LEFT UPPER ARM FISTULA, THE ENDOVASCULAR STENT GRAFT FAILED TO DEPLOY. REPORTEDLY, ANOTHER ENDOVASCULAR DELIVERY SYSTEM WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6699112 ↗
• MalfunctionJul 6, 2017Break; Failure to Advance; Activation, Positioning or Separation Problem; Break; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT UPON INTRODUCING THE ENDOVASCULAR STENT DELIVERY SYSTEM INTO THE PATIENT TO TREAT THE LEFT FOREARM LOOP GRAFT AND STENOSIS AT THE VENOUS ANASTOMOSIS, THE DELIVERY SYSTEM FAILED TO ADVANCE; THEREFORE, THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. REPORTEDLY, ANOTHER ENDOVASCULAR DELIVERY SYSTEM WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6691674 ↗
• InjuryFeb 19, 2016Detachment of Device or Device Component; Detachment Of Device Component; Migration or Expulsion of Device; Retraction Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT POST SUCCESSFUL DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT IN A VENOUS ANASTOMOSIS IN THE BRACHIAL VEIN, THE STENT GRAFT DELIVERY SYSTEM WAS ALLEGEDLY DIFFICULT TO RETRACT. UPON REMOVAL OF THE DELIVERY SYSTEM, THE HEALTH CARE PROVIDER (HCP) NOTICED THAT THE TIP OF THE DELIVERY SYSTEM HAD ALLEGEDLY DETACHED. IT WAS SAID THAT UNDER FLUOROSCOPY, THE HCP WAS ABLE TO LOCATE THE DETACHED TIP AND USED A BALLOON CATHETER IN AN ATTEMPT TO DRAG THE DETACHED TIP BACK INTO THE SHEATH AND REMOVE IT FROM THE PATIENT. THE HCP WAS UNSUCCESSFUL IN THIS ATTEMPT AND THE DETACHED TIP REPORTEDLY MIGRATED TO THE SUBCLAVIAN VEIN. IT WAS FURTHER REPORTED THAT THE HCP IMPLANTED A STENT IN THE SUBCLAVIAN VEIN TO APPOSE THE DETACHED TIP AGAINST THE VESSEL WALL. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 5446993 ↗

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