LifeSpan ePTFE Vascular GraftRecalls & reported problems across all models

We found 10 models of LifeSpan ePTFE Vascular Graft by Lemaitre Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Aug 4, 2016 and May 13, 2026 — classified as 11 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LifeSpan ePTFE Vascular Graft problems

LifeSpan ePTFE Vascular Graft models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LifeSpan ePTFE Vascular Graft R06050

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  7 reports
• LifeSpan ePTFE Vascular Graft R08080C80

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  5 reports
• LifeSpan ePTFE Vascular Graft R06030

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  4 reports
• LifeSpan ePTFE Vascular Graft R06080C80

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  3 reports
• LifeSpan ePTFE Vascular Graft QT47040

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 reports
• LifeSpan ePTFE Vascular Graft T07050C50

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  2 reports
• LifeSpan ePTFE Vascular Graft R06050CS

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• LifeSpan ePTFE Vascular Graft RS47050

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• LifeSpan ePTFE Vascular Graft QT47050

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report
• LifeSpan ePTFE Vascular Graft T08050C50

  Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
  1 report

Recent LifeSpan ePTFE Vascular Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE LIFESPAN GRAFT IN A FEMORAL-TO-FEMORAL (FF) BYPASS PROCEDURE, MINOR LEAKAGE FROM THE GRAFT WAS OBSERVED, CONFIRMED ON THE ANTERIOR SURFACE. THE PROCEDURE HAD ALREADY BEEN COMPLETED AND THE WOUND WAS CLOSED AT THE TIME THE LEAKAGE WAS IDENTIFIED. NO OTHER COMPLICATIONS OR PATIENT INJURY WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25162571 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON APRIL 26, A LIFESPAN GRAFT WAS IMPLANTED IN A LOOP CONFIGURATION DURING AN ARTERIOVENOUS (AV) SHUNT CREATION PROCEDURE. FOLLOWING THE IMPLANTATION, APPROXIMATELY EIGHT PUNCTURES WERE PERFORMED FOR DIALYSIS. SUBSEQUENTLY, GRAFT OCCLUSION WAS OBSERVED AND A THROMBECTOMY WAS SCHEDULED. UPON SURGICAL INCISION FOR THROMBECTOMY, A TEAR WAS IDENTIFIED IN THE INNER LAYER OF THE GRAFT (THE BASE TUBE). THE TEAR IN THE BASE TUBE WAS LOCATED AWAY FROM THE PUNCTURE SITES (THE PHYSICIAN HAS NOT CLEARLY DETERMINED THE CAUSE). IT IS NOTED THAT THERE WAS NO BLOOD LEAKAGE, AS THE OUTER WRAPPING OF THE GRAFT REMAINED INTACT AND FUNCTIONAL. THROMBECTOMY WAS NOT PERFORMED, AND THE TEAR IN THE BASE TUBE WAS SUTURED, CONCLUDING THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. THE GRAFT REMAINS IMPLANTED AND NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327849 ↗
• 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 ↗
• InjuryAug 15, 2024Compatibility Problem; Material Split, Cut or Torn; Compatibility Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PRODUCT WAS SUCCESSFULLY IMPLANTED AND THE GRAFT WAS HEALING VERY WELL. HOWEVER, AFTER 2 MONTHS THE PATIENT RETURNED TO THE HOSPITAL WITH PSEUDOANEURYSM. DURING THE OPERATION TO REPAIR THE PSEUDOANEURYSM, THE SURGEON FOUND THAT THE GRAFT WAS CUTTING FROM THE POINT OF CANNULATION. THE PATIENT IS IN GOOD CONDITION, THE GRAFT HAS BEEN REPLACED WITH A JOTEC GRAFT, AND THE SITUATION IS NOW RESOLVED. IMPLANT DATE: (B)(6) 2024. EXPLANT DATE: (B)(6) 2024. LOT NUMBER: LVG2945.

  Patient problems: Perforation of Vessels

  MAUDE report 19995660 ↗
• MalfunctionJun 18, 2024Fluid/Blood Leak; Structural Problem; Thickening of Material; Fluid/Blood Leak; Structural Problem; Thickening of Material

  IT WAS REPORTED THAT THE LIFESPAN IS THICKER THAN USUAL AND NOT CONFORMING WELL WHEN SUTURED, WHICH CAUSED BLEEDING AT THE SUTURE HOLES DURING A ARTERIOVENOUS BYPASS GRAFT PROCEDURE. THE PROCEDURE LASTED LONGER FROM STOPPING THE BLEEDING. NO FURTHER COMPLICATIONS OR INJURY WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19558927 ↗
• 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 ↗
• InjuryFeb 8, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A THROMBOSIS WITH THE LIFESPAN EPTFE VASCULAR GRAFTS FROM LEMAITRE. THE GRAFT HAD BEEN PUNCTURED FOR USE WHILE IMPLANTED. THE GRAFT WAS IMPLANTED ON (B)(6) 2023. DURING REINTERVENTION, IT WAS DETERMINED THAT THE PTFE DID NOT INCORPORATE PROPERLY. NO OTHER COMPLICATIONS WERE REPORTED. INITIAL REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT THERE ARE (B)(4) CASES WHERE COMPLICATIONS WERE EXPERIENCED INCLUDING INCORPORATION ISSUES, THROMBOSIS AND INFECTION. A REPORT IS BEING SUBMITTED FOR EACH INCIDENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18667927 ↗
• InjuryJul 12, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THE PATIENT DEVELOPED GRAFT THROMBOSIS A DAY AFTER THE PROCEDURE ON (B)(6) 2023. THE CASE WAS FOR AVF IN THE THIGH USING LIFESPAN R06050. THE SURGEON WAS SUPPLIED WITH A REPLACEMENT AND PERFORMED A SECOND SURGERY ON (B)(6) 2023. THE PATIENT STABILIZED POST PROCEDURE AND WAS DOING WELL.

  Patient problems: Thromboembolism

  MAUDE report 17308557 ↗
• 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 ↗

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