Flair® Endovascular Stent Graft FAF07070Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04049519008806), received between May 16, 2016 and Oct 21, 2019 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2019Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  THIS EVENT SUMMARIZES ONE MALFUNCTION. THE INFORMATION REVIEWED INDICATED THAT MODEL FAF07070 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A BREAK, DETACHMENT OF DEVICE/DEVICE COMPONENT, AND DIFFICULT TO REMOVE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214239 ↗
• MalfunctionJan 17, 2019Break; Fracture; Break; Fracture

  IT WAS REPORTED DURING STENT GRAFT PLACEMENT, A GREAT RESISTANCE WAS ALLEGEDLY IDENTIFIED THEREFORE, THE STENT WAS REMOVED. IT WAS FURTHER REPORTED THAT UPON REMOVAL, A FRACTURE WAS IDENTIFIED ON THE REAR END OF THE CATHETER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8258698 ↗
• MalfunctionDec 3, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED DURING STENT GRAFT DEPLOYMENT, THE STENT DID NOT ALLEGEDLY DEPLOY AND GREAT RESISTANCE WAS FELT. IT WAS FURTHER REPORTED THAT THE COAXIAL END OF THE DEVICE WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8126539 ↗
• MalfunctionOct 10, 2018Break; Positioning Failure; Activation, Positioning or Separation Problem; Break; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT UPON REMOVAL OF THE DELIVERY SYSTEM, THE PROXIMAL END OF THE CATHETER WAS ALLEGEDLY FOUND TO BE BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954408 ↗
• MalfunctionAug 10, 2018Break; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS FISTULA SHUNT JUNCTION PROCEDURE, AFTER SUCCESSFULLY PLACING THE STENT GRAFT AND RETRACTING THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM, THE HEALTH CARE PROVIDER IDENTIFIED THE INNER CATHETER WAS ALLEGEDLY BROKEN AND BECAME ALLEGEDLY CAUGHT WITH THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM AND GUIDEWIRE WERE REMOVED AS ONE UNIT. REPORTEDLY, ONCE THE DELIVERY SYSTEM AND THE GUIDEWIRE WERE OUTSIDE OF THE PATIENT IT WAS IDENTIFIED THE TIP OF THE CATHETER HAD DETACHED AND WAS STUCK TO THE GUIDEWIRE. NO ADDITIONAL DEVICE WAS NEEDED SINCE THE STENT GRAFT WAS PLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7773906 ↗
• MalfunctionMay 9, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT ALLEGED FORCE WAS FELT UPON REMOVAL OF THE SAFETY CLIP AND DURING AN ATTEMPT TO DEPLOY THE ENDOVASCULAR STENT GRAFT FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE PROXIMAL END OF THE CATHETER WAS IDENTIFIED ALLEGEDLY BROKEN AND THE STENT GRAFT FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7501046 ↗
• MalfunctionFeb 15, 2018Break; Difficult or Delayed Positioning; Fracture; Break; Difficult or Delayed Positioning; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT WAS ALLEGEDLY MET WITH SOME RESISTANCE DURING DEPLOYMENT ATTEMPT AND THE CATHETER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7273770 ↗
• MalfunctionJan 4, 2018Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE CATHETER WAS ALLEGEDLY BROKEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7164741 ↗
• MalfunctionMar 14, 2017Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM OUTER CATHETER ALLEGEDLY BROKE. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. REPORTEDLY, ANOTHER ENDOVASCULAR 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 6403118 ↗
• MalfunctionDec 1, 2016Positioning Failure; Activation, Positioning or Separation Problem; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE STENT, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE ENDOVASCULAR GRAFT DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6138214 ↗
• MalfunctionNov 21, 2016Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT, THE DELIVERY SYSTEM ALLEGEDLY BROKE. THE DELIVERY SYSTEM AND STENT GRAFT WERE REMOVED WITHOUT INCIDENT AND ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118709 ↗
• MalfunctionSep 1, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT WHILE ATTEMPTING TO DEPLOY THE ENDOVASCULAR STENT GRAFT , THE OUTER SHEATH BROKE; THEREFORE, THE STENT GRAFT WAS UNABLE TO BE DEPLOYED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5923649 ↗
• MalfunctionMay 16, 2016Premature Activation

  IT WAS REPORTED THAT AN ENDOVASCULAR STENT GRAFT WOULD NOT FULLY DEPLOY. IT WAS FURTHER REPORTED THAT APPROXIMATELY HALF OF THE ENDOVASCULAR STENT GRAFT DEPLOYED FROM THE DELIVERY SYSTEM AND THAT THE DELIVERY SYSTEM WITH THE STENT GRAFT HALF WAY DEPLOYED WAS REMOVED FROM THE PATIENT. REPORTEDLY, THE PROCEDURE WAS CONCLUDED AND THE PATIENT WAS TO BE RESCHEDULED FOR ANOTHER TREATMENT DATE. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5658542 ↗

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