LifeSpan ePTFE Vascular Graft R06030Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840663105182), received between Sep 6, 2019 and Jul 1, 2022 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Peeled/Delaminated1
Patient problems
- Hematoma2
- No Clinical Signs, Symptoms or Conditions1
- Post Operative Wound Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2022Peeled/Delaminated; Peeled/Delaminated
PRIOR TO THE ANASTOMOSIS, DURING PREPARING THE LIFESPAN EPTFE VASCULAR GRAFT, A LAYER OF THE GRAFT STARTED TO SEPARATE WHEN THE SURGEON CUT IT ACROSS THE GRAFT. SO, THE SURGEON CUT THE SECTION OF THE GRAFT THAT PEELED AND IMPLANTED THE REMAINING PORTION OF THE GRAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14889823 ↗InjuryNov 8, 2019Fluid/Blood Leak; Fluid/Blood Leak
LIFESPAN EPTFE POLYESTER GRAFT ( CATALOG#: R06030, LOT#: LVG2407 ) WAS IMPLANTED ON (B)(6) 2019 IN THE FOREARM OF A HEMODIALYSIS PATIENT FOR AV ACCESS. THE INITIAL PUNCTURE WAS PERFORMED AFTER 30-40 DAYS ALLOWING THE GRAFT TO INCORPORATE PROPERLY TO ITS SURROUNDING TISSUE. DURING CANNULATION, PERI-PROSTHETIC HEMATOMA OCCURED FREQUENTLY AS THE GRAFT WAS OBSERVED TO BE NOT ADHERING TO ITS SURROUNDING TISSUE. THE GRAFT WAS THEN EXPLANTED ON (B)(6) 2019.
Patient problems: Hematoma
MAUDE report 9297773 ↗InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem
A TOTAL OF 111 GRAFTS FROM LOT# LVG2406 AND LVG2407 WERE IMPLANTED BETWEEN (B)(6) 2019 TO (B)(6) 2019 IN 111 DIFFERENT HEMODIALYSIS PATIENTS TO CREATE AN UPPER LIMB ARTERIOVENOUS. OUT OF THESE 111 GRAFTS, 11 GRAFTS SHOWED SIGNS OF INFECTION AND REQUIRED REMOVAL OF THE GRAFT. THIS IS REPORT 2 OF 3 OF THIS SERIES. PLEASE NOTE THAT WE HAVE REPORTED MFG REPORT# 1220948-2019-00122 AND 1220948-2019-00124 RELATED TO COMPLICATIONS DUE TO THROMBOSIS AND LACK OF GRAFT INCORPORATION TO ITS SURROUNDING TISSUE THAT WERE ALSO ENCOUNTERED IN THIS SERIES.
Patient problems: Post Operative Wound Infection
MAUDE report 8971008 ↗InjurySep 6, 2019Loosening of Implant Not Related to Bone-Ingrowth
A TOTAL OF 111 GRAFTS FROM LOT# LVG2406 AND LVG2407 WERE IMPLANTED BETWEEN MARCH 06, 2019 TO MAY 03, 2019 IN 111 DIFFERENT HEMODIALYSIS PATIENTS TO CREATE AN UPPER LIMB ARTERIOVENOUS. DURING DE-CLOTTING OF THE THROMBOSED GRAFTS, SURGEON OBSERVED A LAYER OF THE GRAFTS WERE COMPLETELY LOOSE IN ITS TUNNEL WITHOUT ANY SIGNS OF INCORPORATION TO ITS SURROUNDING TISSUES. THIS IS REPORT 3 OF 3 OF THIS SERIES. PLEASE NOTE THAT WE HAVE REPORTED MFG REPORT# 1220948-2019-00122 AND 1220948-2019- 00123 RELATED TO COMPLICATIONS DUE TO THROMBOSIS AND INFECTION THAT WERE ALSO ENCOUNTERED IN THIS SERIES.
Patient problems: Hematoma
MAUDE report 8971006 ↗
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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