Flair® Endovascular Stent Graft FAF08050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04049519008837), received between Sep 1, 2016 and Jul 11, 2019 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAF08050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MIGRATION OF DEVICE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE AGE AND WEIGHT WERE NOT REPORTED FOR THE PATIENT INVOLVED. THE REPORTED PATIENT WAS MALE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783171 ↗
• MalfunctionNov 20, 2018Positioning Failure; Material Separation; Positioning Failure; Material Separation

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY IN THE BRACHIAL VEIN VIA AN UPPER ARM GRAFT ACCESS SITE. REPORTEDLY, THE STENT GRAFT DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8091234 ↗
• InjurySep 15, 2017Fracture; Occlusion Within Device; Fracture; Occlusion Within Device

  IT WAS REPORTED THAT APPROXIMATELY POST ONE WEEK OF THE ENDOVASCULAR STENT GRAFT PLACEMENT PROCEDURE IN THE VENOUS ANASTOMOSIS VIA THE LEFT UPPER ARM AN ALLEGED OCCLUSION AND STENT GRAFT FRACTURE WERE IDENTIFIED UNDER GUIDED FLUOROSCOPY. THEREFORE, MEDICAL INTERVENTION WAS REQUIRED; A SECOND STENT WAS DEPLOYED WITHIN THE FIRST DEPLOYED STENT, VIA THE SAME ACCESS. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 6868853 ↗
• InjuryJan 3, 2017Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT POST ENDOVASCULAR STENT DEPLOYMENT, THE DELIVERY SYSTEM ALLEGEDLY BECAME STUCK ON THE COVERED STENT DURING RETRACTION; THEREFORE, THE STENT WITHIN THE VESSEL WAS FURTHER DILATED WITH A PTA BALLOON, CREATING ROOM, AND ALLOWING THE DELIVERY SYSTEM TO BE REMOVED WITHOUT INCIDENT. HOWEVER, AFTER THE DELIVERY SYSTEM WAS REMOVED, THE PATIENT REPORTEDLY EXPERIENCED NATIVE VEIN EXTRAVASATION PROXIMAL TO THE DEPLOYED STENT; THEREFORE, ANOTHER STENT WAS DEPLOYED STOPPING THE BLEEDING AND COMPLETING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6220232 ↗
• InjuryDec 2, 2016Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT, THE DISTAL TIP OF THE INNER CATHETER ALLEGEDLY BROKE AND DETACHED FROM THE ENDOVASCULAR STENT DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER PLACED A BARE METAL STENT TO SECURE THE DISTAL TIP AGAINST THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6143150 ↗
• MalfunctionOct 28, 2016Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT IN THE AXILLARY VEIN, THE STENT GRAFT ALLEGEDLY MOVED FORWARD TO AN UNINTENDED LOCATION. ANOTHER STENT GRAFT WAS USED TO COMPLETE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6063565 ↗
• MalfunctionSep 1, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER SUCCESSFULLY DEPLOYING A STENT GRAFT IN A TIGHT STENOSIS IN THE CEPHALIC ARCH OF A RIGHT UPPER ARM FISTULA; THE HEALTH CARE PROVIDER (HCP) ALLEGEDLY DIDN'T RETRACT THE DELIVERY SYSTEM TIP INTO THE INNER CATHETER PRIOR TO RETRIEVING THE DEVICE. REPORTEDLY, DURING RETRIEVAL THE TIP OF THE DELIVERY SYSTEM BECAME LODGED IN THE STENT GRAFT AND THE TIP DETACHED. THE HCP UNSUCCESSFULLY ATTEMPTED TO RETRIEVE THE TIP WITH A GUIDE WIRE. THE HCP DETERMINED TO LEAVE THE TIP BEHIND AS THERE WAS GOOD BLOOD FLOW. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5922175 ↗

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