LifeSpan ePTFE Vascular Graft R06080C80Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840663105601), received between May 21, 2022 and Feb 11, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Separation” (2 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
- Material Separation2
- Peeled/Delaminated2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Peeled/Delaminated; Material Separation
IT WAS REPORTED THAT DURING A PROCEDURE, THE LIFESPAN EPTFE VASCULAR GRAFT SEPARATED WHEN THE EXTERNAL SPIRAL SUPPORT WAS REMOVED. THE DAMAGED PORTION OF THE GRAFT WAS CUT OFF, AND THE REMAINING USABLE PORTION WAS IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24314150 ↗InjuryApr 17, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE CUSTOMER USED A GRAFT THAT WAS RE-STERILIZED WITH EO GAS. THE PRODUCT WAS USED FOR A FEMORAL-POPLITEAL BYPASS. DURING USE, THE LIFESPAN EPTFE VASCULAR GRAFT OUTER LAYER SEPARATED WHILE REMOVING SPIRAL AT THE PROXIMAL ANASTOMOSIS DURING SUTURING, WITH A LENGTH OF 5-10 MM. THE SEPARATION WAS CONFINED TO THE PROXIMAL SITE OF THE GRAFT, RESULTING IN BLEEDING AT THE SUTURE LINE. THE PATIENT EXPERIENCED BLOOD LOSS OF 350CC FROM SUTURE LINE BLEEDING. THE BLEEDING WAS CONTROLLED BY APPLYING A HEMOSTATIC PRODUCT AT THE PROXIMAL ANASTOMOSIS AND ADMINISTERING VITAMIN K. THE PATIENT WAS STILL IN THE HOSPITAL. NO OTHER INJURIES OR COMPLICATIONS REPORTED TO THE PATIENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21859688 ↗MalfunctionMay 21, 2022Peeled/Delaminated; Peeled/Delaminated
WHEN THE SURGEON ATTEMPTED TO REMOVE THE SPIRAL OF THE LIFESPAN VASCULAR GRAFT, A SECTION OF THE TAPE LAMINATION PEELED OFF. SO, THE SURGEON DID NOT IMPLANT THE GRAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14465954 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page