Flair® Endovascular Stent Graft FAF09050Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04049519008875), received between Jan 8, 2016 and Mar 27, 2019 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE FOR A LEFT A/V FISTULA DE-CLOT, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. THEREFORE, A BALLOON WAS USED TO COMPLETELY DEPLOY THE STENT GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8458575 ↗
• MalfunctionMar 5, 2019Difficult to Advance; Activation Failure; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, THE GUIDEWIRE WAS DIFFICULT TO ADVANCE THROUGH THE INTRODUCER SHEATH. FURTHERMORE, THE STENT GRAFT WAS POSITIONED AT ITS INTENDED BUT ALLEGEDLY FAILED TO EXPAND. IT WAS FURTHER REPORTED THAT THE STENT GRAFT DEPLOYED JUST ENOUGH THAT A BALLOON WAS USED TO COMPLETELY EXPAND THE STENT GRAFT AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8392792 ↗
• MalfunctionJan 8, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER SUCCESSFULLY DEPLOYING THE ENDOVASCULAR STENT GRAFT IN A 10 MM BRACHIAL-BASILIC A/V GRAFT FOR TREATMENT OF RECURRING ANASTOMOSIS, IT WAS IDENTIFIED UNDER FLUOROSCOPY THAT THE STENT GRAFT ALLEGEDLY MIGRATED APPROXIMATELY THREE INCHES UP INTO THE AXILLARY VEIN. IT WAS FURTHER REPORTED THAT A BALLOON WAS USED FOR POST DILATATION AND TO EXPAND THE STENT GRAFT FOR GOOD WALL APPOSITION AND FLOW. THERE WAS NO REPORTED PATIENT INJURY; HOWEVER, THE PATIENT IS SCHEDULED TO REVISIT PHYSICIAN TO BE OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8226893 ↗
• MalfunctionJun 12, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE TIP OF THE CATHETER ALLEGEDLY BROKE OFF WHILE THE STENT WAS LOADING OVER THE WIRE. REPORTEDLY, ANOTHER ENDOVASCULAR STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 7592046 ↗
• InjuryMay 24, 2018Occlusion Within Device; Obstruction of Flow; Malposition of Device; Occlusion Within Device; Obstruction of Flow; Malposition of Device

  IT WAS REPORTED THAT DURING TREATMENT IN THE LEFT UPPER ARM GRAFT AS THE ENDOVASCULAR STENT GRAFT WAS DEPLOYED IN THE LESION THE STENT GRAFT ALLEGEDLY JUMPED FORWARD APPROXIMATELY 2CM. REPORTEDLY, MORE THAN THE USUAL EXCESSIVE FORCE WAS NEEDED TO BEGIN DEPLOYING THE STENT GRAFT. IT WAS FURTHER REPORTED THAT ADDITIONAL ANGIOPLASTY INTERVENTION WAS PERFORMED APPROXIMATELY FIFTEEN DAYS POST STENT GRAFT PLACEMENT AS THERE WAS SOME CLOTTING AND STENOSIS AT THE TRAILING OF THE STENT. THE PATIENT REPORTEDLY WAS PLACED ON PLAVIX MEDICATION. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 7543219 ↗
• MalfunctionMar 19, 2018Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING AN UPPER ARM LOOP GRAFT (OUTPUT/IN FLOW SITE DOUBLE CURVE) PROCEDURE IN THE BASILICA VEIN, A LOT OF FORCE WAS ALLEGEDLY FELT DURING DEPLOYMENT AND THE STENT GRAFT ALLEGEDLY JUMPED APPROXIMATELY 5CC FROM THE INTENDED LOCATION WHEN IT FINALLY DEPLOYED. THEREFORE, THE CATHETER WAS REMOVED WITHOUT INCIDENT AND ANOTHER STENT GRAFT WAS USED, OVERLAP TECHNIQUE, TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7349609 ↗
• InjuryFeb 12, 2018Fracture; Detachment of Device or Device Component; Activation Failure; Fracture; Detachment of Device or Device Component; Activation Failure

  IT WAS REPORTED THAT WHILE DEPLOYING THE ENDOVASCULAR STENT GRAFT FOR A DE-CLOT PROCEDURE IN THE OUTFLOW A/V FISTULA GRAFT, A PORTION OF THE STENT GRAFT ALLEGEDLY FAILED TO EXPAND FROM THE PROXIMAL END (FROM PROVIDER TO PATIENT). THEREFORE, THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUES, BUT THE STENT GRAFT HAD TO BE SURGICALLY REMOVE VIA THE VESSEL. REPORTEDLY, A HEMODIALYSIS CATHETER WAS PLACED IN THE TREATMENT AREA; THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7265163 ↗
• MalfunctionDec 5, 2017Bent; Break; Positioning Failure; Bent; Break; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY DID NOT DEPLOY AT THE VENOUS ANASTOMOSIS OF A FOREARM LOOP GRAFT DURING AN ATTEMPT TO DEPLOY THROUGH A TIGHT TURN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085286 ↗
• MalfunctionOct 26, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT IN AN UPPER ARM LOOP GRAFT AT THE VENOUS ANASTOMOSIS, UPON REMOVAL OF THE DEPLOYMENT SYSTEM GUIDED FLUOROSCOPY DEMONSTRATED THE DISTAL RADIOPAQUE MARKER (DISTAL TIP OF THE DEPLOYMENT SYSTEM) WAS LOCATED AT THE PROXIMAL END OF THE VASCULAR STENT; THE DISTAL TIP REMAINED ON THE GUIDEWIRE. REPORTEDLY, RIGHT FEMORAL ACCESS WAS GAINED AND A SNARE WAS USED TO REMOVE THE DETACHED TIP OF THE DELIVERY SYSTEM. THE SNARE DEVICE AND DETACHED TIP WERE REMOVED WITH THE INTRODUCER SHEATH AS ONE UNIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6981900 ↗
• MalfunctionOct 13, 2017Break; Positioning Failure; Retraction Problem; Break; Positioning Failure; Retraction Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE INTENDED FOR AN ANEURYSM IN THE UPPER EXTREMITY WITH ACCESS THROUGH THE BASILIC VEIN, THE ANATOMY OF THE TRACKING VESSEL WAS TORTUOUS AND THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM TO THE TARGET LESION. REPORTEDLY, THE STENT GRAFT FAILED TO DEPLOY IN THE TARGET LESION AND THERE WAS RESISTANCE DURING DEPLOYMENT ATTEMPT THEREFORE THE HEALTH CARE PROVIDER DETERMINED TO REMOVE THE DEVICE. UPON REMOVAL OF THE DEVICE FROM THE PATIENT'S BODY, THE STENT GRAFT ALLEGEDLY DEPLOYED INSIDE THE INTRODUCER SHEATH. FURTHERMORE, THERE WAS DIFFICULTY RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950328 ↗
• MalfunctionAug 2, 2017Retraction Problem; Malposition of Device; Retraction Problem; Malposition of Device

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT IN THE A/V GRAFT STENOSIS, THE ENDOVASCULAR GRAFT DELIVERY SYSTEM ALLEGEDLY BECAME CAUGHT WITHIN THE STENT; THEREFORE, A PTA BALLOON WAS INFLATED TO FURTHER EXPAND THE STENT. AS A RESULT, THE DEPLOYED STENT EXPANDED SLIGHTLY FROM THE PLACEMENT SITE. THEREFORE, A SECOND ENDOVASCULAR STENT GRAFT WAS DEPLOYED TO OVERLAP THE STENT PLACEMENT SITE. IT WAS FURTHER REPORTED THAT AN 8MM PTA BALLOON WAS USED TO POST DILATE THE STENTS RESULTING IN GOOD FLOW WITHIN THE VESSEL. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6762169 ↗
• MalfunctionJul 31, 2017Positioning Failure; Disconnection; Material Separation; Positioning Failure; Disconnection; Material Separation

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN THE LEFT THIGH VENOUS ANASTOMOSIS, THE TUOHY-BORST VALVE ALLEGEDLY DISCONNECTED FROM THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM PREVENTING THE STENT GRAFT FROM ALLEGEDLY BEING DEPLOYED. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT 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 6755633 ↗
• MalfunctionJun 30, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING TREATMENT OF THE LEFT UPPER ARM GRAFT, VENOUS ANASTOMOSIS, THE FLARED END OF THE STENT GRAFT WAS ALLEGEDLY ON THE PROXIMAL END OF THE STENT RATHER THAN THE DISTAL END AND IT ALLEGEDLY MIGRATED A FEW INCHES FROM THE STENT PLACEMENT SITE. IT WAS FURTHER REPORTED THAT A PTA BALLOON WAS USED TO POST-DILATE AND EXPAND THE STENT, ALLOWING THE STENT TO BE RETURNED TO THE INTENDED PLACEMENT SITE. REPORTEDLY, A SECOND STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6682494 ↗
• MalfunctionMay 17, 2017Break; Break

  IT WAS REPORTED THAT DURING AN ATTEMPT TO DEPLOY THE ENDOVASCULAR STENT GRAFT IN AN UPPER ARM, THE OUTER CATHETER SHEATH AND THE HANDLE OF THE DELIVERY SYSTEM ALLEGEDLY BROKE. 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 6572862 ↗
• MalfunctionAug 30, 2016Positioning Failure; Material Separation; Positioning Failure; Material Separation

  IT WAS REPORTED THAT DURING DEPLOYMENT, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY IN THE UPPER RIGHT ARM OF AN A/V GRAFT. IT WAS FURTHER REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY BECAME LOOSE AT THE HANDLE. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. 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 5916437 ↗
• MalfunctionJan 8, 2016Break

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN A DIALYSIS SHUNT, THE OUTER CATHETER BROKE; HOWEVER, THE STENT GRAFT WAS DEPLOYED SUCCESSFULLY. THERE WAS NO PATIENT INJURY REPORTED.

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

  MAUDE report 5355570 ↗

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