Fluency® Endovascular Stent Graft FEL10060Recalls & reported problems
Bard Peripheral Vascular, Inc. · FLUENCY® PLUS Endovascular Stent Graft 10 mm x 60 mm (117 cm delivery system) · Class 3 · Implant
All models of Fluency Endovascular Stent Graft (51)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519008240), received between Aug 10, 2016 and Aug 10, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).
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
Device problems
- Activation, Positioning or Separation Problem1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2016Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT, THE OUTER SHEATH OF THE DELIVERY SYSTEM FRACTURED; HOWEVER, THE STENT GRAFT COULD BE DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5864664 ↗
Other System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment devices
- COVERA AVSM10060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall33 reports
- COVERA AVSM08060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall21 reports
- COVERA AVSM09060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall18 reports
- COVERA AVSM10080Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall16 reports
- COVERA AVSM10040Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall15 reports
- COVERA AVFM10060Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall14 reports
- COVERA AVSM09080Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall1 death14 reports
- COVERA AVSM10100Angiomed GmbH & Co. Medizintechnik KG · System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment1 recall13 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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