Flair® Endovascular Stent Graft FAF08070Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04049519008844), received between Nov 11, 2015 and Mar 15, 2016 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 15, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ATTEMPT TO IMPLANT AN ENDOVASCULAR STENT GRAFT IN AN A-V GRAFT AT THE ANASTOMOSIS OF THE AXILLARY VEIN, THE STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY. IT WAS FURTHER REPORTED THAT THE STENT GRAFT WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. REPORTEDLY ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5501938 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT THE STENT GRAFT WAS UNABLE TO BE DEPLOYED IN AN A-V FISTULA. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO DEPLOY THE STENT GRAFT, THE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT WAS DEPLOYED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5219158 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT A STENT GRAFT COULD NOT BE DEPLOYED; THEREFORE, IT WAS EXCHANGED OVER THE GUIDE WIRE FOR NEW STENT GRAFT THAT WAS DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218910 ↗
• MalfunctionNov 11, 2015Break; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT, THE DISTAL TIP OF THE CATHETER WAS DISCOVERED TO BE BROKE. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 5218871 ↗
• MalfunctionNov 11, 2015Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, ADDITIONAL MANIPULATION OF THE STENT GRAFT WAS NEEDED TO COMPLETE THE DEPLOYMENT SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218870 ↗
• MalfunctionNov 11, 2015Positioning 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 WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218577 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT FOLLOWING ANGIOPLASTY IN A VASCULAR STENT WITH STENOSIS IN A SUBCLAVIAN GRAFT, THE STENT GRAFT COULD NOT BE DEPLOYED; THEREFORE, THE STENT GRAFT WAS EXCHANGED OVER THE GUIDE WIRE FOR A PTA BALLOON TO COMPLETE A SUCCESSFUL ANGIOPLASTY. THE VESSEL WAS REPORTED TO BE PATENT WITH GOOD BLOOD FLOW. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218154 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN AN AV GRAFT, THE STENT GRAFT WAS UNABLE TO BE DEPLOYED. 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 5218132 ↗
• MalfunctionNov 11, 2015Break; Positioning 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 Consequences Or Impact To Patient

  MAUDE report 5218102 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT IN AN A-V FISTULA OF THE UPPER ARM, THE STENT GRAFT COULD NOT BE DEPLOYED. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO DEPLOY THE STENT GRAFT, 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

  MAUDE report 5218053 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT THE STENT GRAFT WAS UNABLE TO BE DEPLOYED. THE ENTIRE DEVICE WAS REMOVED WITHOUT INCIDENT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5218013 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN A LOOP GRAFT, THE OUTER CATHETER BROKE. ANOTHER STENT GRAFT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217965 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217919 ↗
• MalfunctionNov 11, 2015Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN AN AV GRAFT, 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 PATEINT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217870 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT A STENT GRAFT COULD NOT BE DEPLOYED DUE TO RESISTANCE IN THE DEPLOYMENT SYSTEM. THE STENT GRAFT WAS EXCHANGED OVER THE GLIDE WIRE FOR NEW STENT GRAFT THAT WAS DEPLOYED SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217463 ↗
• MalfunctionNov 11, 2015Positioning Failure

  IT WAS REPORTED THAT DURING AN ATTEMPT TO IMPLANT AN ENDOVASCULAR STENT GRAFT IN AN A-V GRAFT AT THE ANASTOMOSIS OF THE AXILLARY VEIN, THE STENT GRAFT WOULD NOT DEPLOY. THE STENT GRAFT WAS REMOVED WITHOUT INCIDENT AND ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5217294 ↗
• MalfunctionNov 11, 2015Difficult or Delayed Positioning

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE IN THE CEPHALIC VEIN, THE STENT GRAFT WAS UNABLE TO PASS OVER THE GUIDE WIRE; HOWEVER, AFTER SEVERAL ADDITIONAL ATTEMPTS WERE MADE, THE VASCULAR STENT WAS ABLE TO PASS OVER THE GUIDE WIRE AND WAS DEPLOYED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5217125 ↗
• MalfunctionNov 11, 2015Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDE WIRE COULD NOT BE LOADED INTO THE DELIVERY SYSTEM; THEREFORE, A NEW STENT GRAFT SYSTEM WAS PREPPED AND DEPLOYED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 5217121 ↗

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