Flair® Endovascular Stent Graft FAS07070Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04049519008967), received between Jan 8, 2016 and Oct 15, 2019 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2019Malposition of Device; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS07070 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193021 ↗
• MalfunctionFeb 14, 2019Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT, THE OUTER CATHETER OF THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FRACTURED AND WOULD NOT DEPLOY. REPORTEDLY, THE SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8339504 ↗
• MalfunctionNov 14, 2018Break; Positioning Failure; Activation, Positioning or Separation Problem; Break; Positioning Failure; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A STENT DEPLOYMENT IN LEFT UPPER ARM, THE STENT GRAFT WAS ALLEGEDLY UNABLE TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8069809 ↗
• 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 7953925 ↗
• MalfunctionJul 17, 2018Break; Positioning Failure; Difficult to Advance; Break; Positioning Failure; Difficult to Advance

  IT WAS REPORTED THAT THE PROXIMAL END OF THE ENDOVASCULAR STENT GRAFT CATHETER ALLEGEDLY BROKE AS AN ATTEMPT WAS MADE TO DEPLOY THE STENT GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695907 ↗
• MalfunctionMar 27, 2018Fracture; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374371 ↗
• MalfunctionNov 10, 2017Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT GRAFT ALLEGEDLY BROKE BETWEEN THE SHAFT AND THE CATHETER DURING DEPLOYMENT IN AN A/V GRAFT. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT AND TWO SMALLER IN SIZE STENTS WERE USED, OVERLAPPING TECHNIQUE, IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023091 ↗
• MalfunctionMay 16, 2017Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE STENT THE HEALTH CARE PROVIDER ALLEGEDLY EXPERIENCE RESISTANCE DURING TREATMENT IN THE BRACHIAL ARTERY GRAFT VIA THE BASILICA ARTERY. IT WAS FURTHER REPORTED THAT THE CATHETER WAS REMOVED WITHOUT INCIDENT AND WAS IDENTIFIED TO BE BROKEN. REPORTEDLY, A PTA BALLOON WAS THEN USED TO CONTINUE THE PROCEDURE, AND ANGIOPLASTY WAS PERFORMED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6571310 ↗
• MalfunctionNov 8, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE STENT, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE ENDOVASCULAR GRAFT DELIVERY SYSTEM IN THE AV FISTULA; THEREFORE, THE GRAFT DELIVERY SYSTEM WAS RETRIEVED WITHOUT INCIDENT. IT WAS FURTHER REPORTED THAT TWO SMALLER SIZE STENTS WERE OVERLAPPED IN THE STENT PLACEMENT SITE, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6087238 ↗
• MalfunctionMay 18, 2016Break; Activation, Positioning or Separation Problem; Break

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED AND THEN WOULD NOT DEPLOY ANY FURTHER. IT WAS FURTHER REPORTED THAT THE STENT GRAFT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND AN ALLEGED BREAK IN THE OUTER CATHETER WAS IDENTIFIED. REPORTEDLY, THE HEALTH CARE PROVIDER CONCLUDED THE PROCEDURE AND THE PATIENT/PROCEDURE WAS TO BE RESCHEDULED. THERE WAS NO REPORTED IMPACT OR CONSEQUENCE TO THE PATIENT.

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

  MAUDE report 5665494 ↗
• MalfunctionFeb 23, 2016Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY. THERE WAS NO REPORTED RETRACTION DIFFICULTY THROUGH THE SHEATH. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5454427 ↗
• MalfunctionJan 8, 2016Positioning Failure; Device Inoperable

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A STENT GRAFT IN A PSEUDOANEURYSM IN AN AV GRAFT, THE DEPLOYMENT SYSTEM WAS UNRESPONSIVE AND THE STENT GRAFT WOULD NOT DEPLOY. THE STENT GRAFT SYSTEM WAS REMOVED AND ANOTHER STENT GRAFT WAS IMPLANTED WITHOUT ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5355086 ↗

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