LifeSpan ePTFE Vascular Graft T07050C50Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840663105687), received between Jul 31, 2025 and Aug 28, 2025 — classified as 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
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2025Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation
IT WAS REPORTED THAT AFTER CUTTING THE LIFESPAN TO THE APPROPRIATE LENGTH, THE OUTER COATING PEELED OFF TOGETHER WITH THE SPIRAL SUPPORT DURING REMOVAL. THE PEELED COATING LOOKED LIKE IT HAD BEEN SHREDDED INTO FIBROUS STRANDS. THE PEELED COATING WAS CAREFULLY TRIMMED, AND THE LIFESPAN WAS USED AS IS. NO INJURY WAS REPORTED TO THE PATIENT. NOTE: ADDITIONAL INFORMATION RELATED TO THE COMPLAINT WAS RECEIVED ON 27AUG2025 INDICATING THAT A SECOND OCCURRENCE OF THIS ISSUE OCCURRED ON AN UNKNOWN DATE. AT THE TIME OF THE ORIGINAL COMPLAINT, IT WAS ONLY REPORTED THAT 1 FAILURE OCCURRED (REFERENCE EMDR 1220948-2025-00128). THIS IS REPORT 2 OF 2 RELATED TO THE SECOND PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911848 ↗MalfunctionJul 31, 2025Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation
IT WAS REPORTED THAT AFTER CUTTING THE LIFESPAN TO THE APPROPRIATE LENGTH, THE OUTER COATING PEELED OFF TOGETHER WITH THE SPIRAL SUPPORT DURING REMOVAL. THE PEELED COATING LOOKED LIKE IT HAD BEEN SHREDDED INTO FIBROUS STRANDS. THE PEELED COATING WAS CAREFULLY TRIMMED, AND THE LIFESPAN WAS USED AS IS. NO INJURY WAS REPORTED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22680020 ↗
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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