Flair Endovascular Stent GraftRecalls & reported problems across all models

We found 20 models of Flair Endovascular Stent Graft by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 155 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2015 and Oct 26, 2020 — classified as 7 injuries, 148 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (85 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Flair Endovascular Stent Graft problems

Flair Endovascular Stent Graft models

20 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Flair® Endovascular Stent Graft FAS08070

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  27 reports
• Flair® Endovascular Stent Graft FAS08050

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  23 reports
• Flair® Endovascular Stent Graft FAF08070

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  18 reports
• Flair® Endovascular Stent Graft FAF09050

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  16 reports
• Flair® Endovascular Stent Graft FAF07070

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  13 reports
• Flair® Endovascular Stent Graft FAS07070

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  12 reports
• Flair® Endovascular Stent Graft FAF07050

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  9 reports
• Flair® Endovascular Stent Graft FAS07050

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  8 reports
• Flair® Endovascular Stent Graft FAS09050

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  8 reports
• Flair® Endovascular Stent Graft FAF08050

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  7 reports
• Flair® Endovascular Stent Graft FAS08040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  4 reports
• Flair® Endovascular Stent Graft FAF09040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Flair® Endovascular Stent Graft FAF06050

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Flair® Endovascular Stent Graft FAF07040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Flair® Endovascular Stent Graft FAF08040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Flair® Endovascular Stent Graft FAS06040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Flair® Endovascular Stent Graft FAS06050

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Flair® Endovascular Stent Graft FAS06070

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Flair® Endovascular Stent Graft FAS07040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Flair® Endovascular Stent Graft FAS09040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report

Recent Flair Endovascular Stent Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2020Positioning Failure; Positioning Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS08050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD PATIENT INVOLVEMENT, BUT THE PATIENT HAD NO CONSEQUENCES. THE (B)(6) YEAR OLD FEMALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10735127 ↗
• MalfunctionJul 16, 2020Break; Retraction Problem; Break; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAF07050 FLAIR ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD PATIENT INVOLVEMENT BUT THE PATIENT HAD NO CONSEQUENCES. THE PATIENT'S AGE AND WEIGHT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10286808 ↗
• MalfunctionApr 13, 2020Break; Positioning Failure; Break; Positioning Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS09050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED BREAK AND FAILURE TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954690 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 15, 2019Break; Positioning Failure; Break; Positioning Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS09050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A BREAK AND FAILED TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE 50 YEAR OLD MALE PATIENT¿S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9193015 ↗
• MalfunctionJul 11, 2019Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FAS09050 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A DEPLOYMENT ISSUE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCE. THE PATIENT WAS REPORTED AS A (B)(6) YEAR-OLD MALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783201 ↗
• 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 ↗
• MalfunctionApr 12, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN A BASILICA VEIN FISTULA IN THE SWING POINT SECTION, THE STENT ALLEGEDLY JUMPED THREE INCHES BEYOND THE INTENDED TARGET LOCATION. ANOTHER STENT WAS DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509156 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 30, 2019Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN A SEVERELY STENOSED LEFT CEPHALIC ARCH VIA ACCESS THROUGH A LEFT CEPHALIC DIALYSIS FISTULA, THE TIP OF THE DELIVERY CATHETER ALLEGEDLY BROKE AND BECAME STUCK IN THE TREATMENT SITE AFTER DEPLOYMENT OF THE STENT GRAFT . THEREFORE, THE DELIVERY SYSTEM WAS DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8291396 ↗
• 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 ↗
• MalfunctionJan 10, 2019Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE TO TREAT ANASTOMOSIS OF A GRAFT IN THE LEFT UPPER EXTREMITY, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8236358 ↗

Other Bard Peripheral Vascular, Inc. products

• MAX-CORE11 models · 8,845 reports · 1 recall
• DENALI Vena Cava Filter2 models · 1,021 reports
• MAGNUM19 models · 571 reports · 1 recall
• Conquest32 models · 560 reports
• Ultraverse RX56 models · 536 reports
• Fluency Endovascular Stent Graft51 models · 532 reports
• Atlas Gold33 models · 427 reports
• Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports