Fluency Endovascular Stent GraftRecalls & reported problems across all models

We found 51 models of Fluency Endovascular Stent Graft by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 532 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2015 and Sep 29, 2026 — classified as 3 deaths, 49 injuries, 480 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (301 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 Fluency Endovascular Stent Graft problems

Fluency Endovascular Stent Graft models

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

• Fluency® Endovascular Stent Graft FEM12060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 death46 reports
• Fluency® Endovascular Stent Graft FEM10120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  39 reports
• Fluency® Endovascular Stent Graft FEM12040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  35 reports
• Fluency® Endovascular Stent Graft FEM14060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  32 reports
• Fluency® Endovascular Stent Graft FEM14120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 deaths29 reports
• Fluency® Endovascular Stent Graft FEM08060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  26 reports
• Fluency® Endovascular Stent Graft FEM14040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  25 reports
• Fluency® Endovascular Stent Graft FEM14080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  24 reports
• Fluency® Endovascular Stent Graft FEM08040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  23 reports
• Fluency® Endovascular Stent Graft FEM10080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  23 reports
• Fluency® Endovascular Stent Graft FEM10100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  19 reports
• Fluency® Endovascular Stent Graft FEM10060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  18 reports
• Fluency® Endovascular Stent Graft FEM12080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  16 reports
• Fluency® Endovascular Stent Graft FEM07060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  15 reports
• Fluency® Endovascular Stent Graft FEM08080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  15 reports
• Fluency® Endovascular Stent Graft FEM08120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  13 reports
• Fluency® Endovascular Stent Graft FEM12120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  12 reports
• Fluency® Endovascular Stent Graft FEM08100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  9 reports
• Fluency® Endovascular Stent Graft FEM09080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  8 reports
• Fluency® Endovascular Stent Graft FEM07080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  7 reports
• Fluency® Endovascular Stent Graft FEL10080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  6 reports
• Fluency® Endovascular Stent Graft FEM06080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  6 reports
• Fluency® Endovascular Stent Graft FEM09060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  6 reports
• Fluency® Endovascular Stent Graft FEM09120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  6 reports
• Fluency® Endovascular Stent Graft FEM10040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  6 reports
• Fluency® Endovascular Stent Graft FEM09040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  5 reports
• Fluency® Endovascular Stent Graft FEM09100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  5 reports
• Fluency® Endovascular Stent Graft FEM14100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  5 reports
• Fluency® Endovascular Stent Graft FEL12060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  4 reports
• Fluency® Endovascular Stent Graft FEL12120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  4 reports
• Fluency® Endovascular Stent Graft FEM06060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  4 reports
• Fluency® Endovascular Stent Graft FEM06100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  4 reports
• Fluency® Endovascular Stent Graft FEM07120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  4 reports
• Fluency® Endovascular Stent Graft FEM12100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  4 reports
• Fluency® Endovascular Stent Graft FEL08060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  3 reports
• Fluency® Endovascular Stent Graft FEL10120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  3 reports
• Fluency® Endovascular Stent Graft FEL06080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Fluency® Endovascular Stent Graft FEL07080

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Fluency® Endovascular Stent Graft FEL09120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Fluency® Endovascular Stent Graft FEL14040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Fluency® Endovascular Stent Graft FEL14100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Fluency® Endovascular Stent Graft FEM06120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Fluency® Endovascular Stent Graft FEM07040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Fluency® Endovascular Stent Graft FEM07100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  2 reports
• Fluency® Endovascular Stent Graft FEL06100

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Fluency® Endovascular Stent Graft FEL06120

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Fluency® Endovascular Stent Graft FEL07060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Fluency® Endovascular Stent Graft FEL08040

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Fluency® Endovascular Stent Graft FEL09060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Fluency® Endovascular Stent Graft FEL10060

  System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
  1 report
• Fluency® Endovascular Stent Graft FEL14060

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

Recent Fluency 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.

• MalfunctionSep 29, 2026Positioning Failure; Misfire

  On (b)(6)2026, a patient underwent a stent placement procedure using a Flunecy Plus device for subclavian and recurrent stenosis. Reportedly, the stent did not deploy, resulting in partial deployment misfire of the stent delivery system, with the stent remaining in a partially deployed condition and the outer sheath becoming heavily elongated. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928448 ↗
• MalfunctionJul 27, 2026Fracture; Misfire; Malposition of Device; Detachment of Device or Device Component

  On (b)(6) 2026, a 74-year-old male patient underwent treatment for femoral artery stenosis/iliac artery aneurysm via angiography using a Fluency Plus Endovascular Stent Graft at the left upper arm venous graft anastomosis site. During the stent procedure, the Fluency stent failed to fully deploy. The delivery system detached and became loose, resulting in unintended stent movement during the attempted deployment. Additionally, the sheath fractured during the procedure. The patient is stable, and there was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50021161 ↗
• MalfunctionJul 15, 2026Difficult or Delayed Positioning; Detachment of Device or Device Component

  On (b)(6) 2026, a patient underwent a stent placement procedure using a Fluency Plus Endovascular Stent Graft for the treatment of stenosis at the venous anastomosis via a left upper arm graft. During the procedure, while the stent was being deployed, it was observed that the clear plastic knob on the back of the Tuohy was loose and became disconnected, making stent deployment more difficult. The patient is doing well, with no reported complications during or after the procedure. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25822439 ↗
• MalfunctionApr 24, 2026Break; Difficult to Advance

  ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING FLUENCY PLUS. REPORTEDLY, FLUENCY DEPLOYED IN THE COMMON ILIAC, RESISTANCE ADVANCING THEY DELIVERY SYSTEM, STENT BROKE IN THE PATIENT, AND THEY HAD TO SNARE OUT PIECES OF THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979530 ↗
• MalfunctionApr 13, 2026Positioning Failure; Misfire

  ON (B)(6) 2026, A PATIENT UNDERWENT ANGIOPLASTY STENT PLACEMENT PROCEDURE USING FLUENCY PLUS ENDOVASC STENT GRAFT. DURING THE PROCEDURE, IT WAS NOTICED THAT THE FLUENCY STENT ALLEGEDLY DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24856543 ↗
• MalfunctionApr 2, 2026Failure to Advance; Misfire; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A FLUENCY STENT. DURING ADVANCEMENT OF THE STENT OVER THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED, PROMPTING REMOVAL OF THE DEVICE. UPON REMOVAL, A KINK IN THE STENT WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761946 ↗
• MalfunctionMar 25, 2026Premature Activation

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE FLUENCY PLUS ENDOVASCULAR STENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THEY ATTEMPTED TO BAR BACK THE STENT, BUT UPON ENTERING THE PATIENT, THE STENT ALLEGEDLY PREMATURELY DEPLOYED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685099 ↗
• MalfunctionMar 3, 2026Break; Migration or Expulsion of Device; Malposition of Device; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE BY USING THE FLUENCY STENT SYSTEM. IT WAS REPORTED THAT DURING DEPLOYMENT, THE DEPLOYMENT SYSTEM EXPERIENCED A MECHANICAL FAILURE AND ALLEGEDLY BROKE OFF. DESPITE THE BREAKAGE, THE FLUENCY STENT WAS FULLY DEPLOYED, AND THE DEPLOYMENT SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT COMPLICATION. IT WAS NOTED THAT THE STENT WAS INADVERTENTLY RETRACTED APPROXIMATELY 1TO 2 CM FROM THE INTENDED LANDING ZONE. THE IMPLANTING PHYSICIAN CONFIRMED THAT ALTHOUGH THE FINAL POSITION WAS NOT IDEAL, THE CLINICAL OUTCOME REMAINED ACCEPTABLE. SUBSEQUENT INVESTIGATION INDICATED THAT THE HEMOSTATIC VALVE OF THE TOUHY BORST Y ADAPTER MAY HAVE BEEN EXCESSIVELY LOOSENED, LEADING TO THE VALVE DETACHING DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493969 ↗
• MalfunctionFeb 17, 2026Fracture; Misfire

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE FLUENCY DEVICE. THE DEVICE WAS PREPARED IN THE STANDARD MANNER AND ADVANCED TO THE INTENDED POSITION. DEPLOYMENT WAS INITIATED; HOWEVER, THE DEVICE WAS UNABLE TO COMPLETE THE DEPLOYMENT PROCESS. SIGNIFICANT PULLING FORCE WAS APPLIED IN AN ATTEMPT TO ACHIEVE FULL DEPLOYMENT, DURING WHICH THE DEVICE FRACTURED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361886 ↗
• MalfunctionFeb 16, 2026Positioning Failure; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE FOR INTRAGRAFT VIA THE RIGHT UPPER ARM USING FLUENCY PLUS ENDOVASCULAR STENT GRAFT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT ALLEGEDLY DID NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342490 ↗
• MalfunctionFeb 13, 2026Break; Misfire

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING FLUENCY FOR POPLITEAL ANEURYSM IN PATIENT WITH HEPARIN ALLERGY VIA CONTRALATERAL FEMORAL ARTERY. REPORTEDLY, THE STENT MALFUNCTIONED AND ALLEGEDLY BROKEN. THE DEVICE WAS PARTIALLY DEPLOYED AND EVENTUALLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330033 ↗
• MalfunctionFeb 10, 2026Break; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A FLUENCY PLUS ENDOVASCULAR STENT GRAFT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT DEPLOYED SUCCESSFULLY, BUT WHILE REMOVING THE STENT SHAFT, THE TIP BROKE OFF AND HAD TO BE RETRIEVED USING A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301885 ↗
• MalfunctionJan 9, 2026Entrapment of Device; Material Perforation; Misfire; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING FLUENCY STENT. DURING THE PROCEDURE THE STENT HAD STRUT STICKING OUT PRE DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018126 ↗
• MalfunctionDec 12, 2025Positioning Failure; Material Separation; Positioning Failure; Material Separation

  A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING FLUENCY PLUS STENT. IT WAS REPORTED THAT THE FLUENCY DID NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787762 ↗
• MalfunctionDec 4, 2025Misfire; Misfire

  A PATIENT UNDERWENT STENT GRAFT PLACEMENT PROCEDURE USING FLUENCY STENT GRAFT. DURING PROCEDURE, THE STENT PARTIAL DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714961 ↗

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
• Atlas Gold33 models · 427 reports
• Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
• Dorado49 models · 387 reports