LifeSpan ePTFE Vascular Graft R08080C80Recalls & reported problems
Lemaitre Vascular, Inc. · LifeSpan ePTFE Vascular Graft · Class 2 · Implant
All models of LifeSpan ePTFE Vascular Graft (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840663105649), received between Feb 17, 2023 and Feb 17, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (4 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, 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.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated4
- Failure to Seal1
- Material Discolored1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT FOUR LIFESPAN GRAFT EXTERNAL SUPPORT BECAME UNDONE AFTER TUNNELING DURING A PERIPHERAL BYPASS LOWER EXTREMITY PROCEDURE. IT WAS NOT DETERMINED IF THE GRAFTS WERE CHECKED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 4 OF 4 RELATED TO THE FIRST GRAFT USED IN THE EVENT. REPORT 1220948-2024-00047, 1220948-2024-00048, AND 1220948-2024-00049 WERE SUBMITTED FOR THE FIRST, SECOND, AND THIRD DEVICES INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728219 ↗MalfunctionFeb 17, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT FOUR LIFESPAN GRAFT EXTERNAL SUPPORT BECAME UNDONE AFTER TUNNELING DURING A PERIPHERAL BYPASS LOWER EXTREMITY PROCEDURE. IT WAS NOT DETERMINED IF THE GRAFTS WERE CHECKED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 2 OF 4 RELATED TO THE SECOND GRAFT USED IN THE EVENT. REPORT 1220948-2024-00047, 1220948-2024-00049, AND 1220948-2024-00050 WERE SUBMITTED FOR THE FIRST, THIRD, AND FOURTH DEVICES INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728218 ↗MalfunctionFeb 17, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT FOUR LIFESPAN GRAFT EXTERNAL SUPPORT BECAME UNDONE AFTER TUNNELING DURING A PERIPHERAL BYPASS LOWER EXTREMITY PROCEDURE. IT WAS NOT DETERMINED IF THE GRAFTS WERE CHECKED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 3 OF 4 RELATED TO THE THIRD GRAFT USED IN THE EVENT. REPORT 1220948-2024-00047, 1220948-2024-00048, AND 1220948-2024-00050 WERE SUBMITTED FOR THE FIRST, SECOND, AND FOURTH DEVICES INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728217 ↗MalfunctionFeb 17, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT FOUR LIFESPAN GRAFT EXTERNAL SUPPORT BECAME UNDONE AFTER TUNNELING DURING A PERIPHERAL BYPASS LOWER EXTREMITY PROCEDURE. IT WAS NOT DETERMINED IF THE GRAFTS WERE CHECKED PRIOR TO USE. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: THIS IS REPORT 1 OF 4 RELATED TO THE FIRST GRAFT USED IN THE EVENT. REPORT 1220948-2024-00048, 1220948-2024-00049, AND 1220948-2024-00050 WERE SUBMITTED FOR THE SECOND, THIRD, AND FOURTH DEVICES INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728215 ↗MalfunctionFeb 17, 2023Material Discolored; Failure to Seal; Material Discolored; Failure to Seal
IT WAS REPORTED LIFESPAN EPTFE VASCULAR GRAFT MOISTENS AND DISCOLORS TO RED AFTER IMPLANTATION. FURTHERMORE, THERE IS NO SPONTANEOUS CLOSURE OF NEEDLE PUNCTURE AFTER DEAIRING EVEN AFTER PRESSURE FOR MORE THAN 30 MINUTES. A GAUGE 23 NEEDLE ANGULATED TO 30 DEGREES WAS USED DURING DEAIRING. GRAFT WAS ANASTOMOSED TO THE AXILLARY ARTERY RIGHT TO THE RIGHT FEMORAL ARTERY. CROSSOVER BYPASS FEMORAL ARTERY TO FEMORAL ARTERY DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16397441 ↗
Other Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 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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