LifeSpan ePTFE Vascular Graft R06050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840663105199), received between Aug 4, 2016 and Jun 25, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJun 16, 2022Peeled/Delaminated; Peeled/Delaminated

  PRIOR TO ANASTOMOSIS, DURING PREPARING THE GRAFT, A LAYER OF THE GRAFT STARTED TO SEPARATE WHEN THE SURGEON CUT IT ACROSS THE GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14717992 ↗
• MalfunctionAug 4, 2016Fluid/Blood Leak; Fluid/Blood Leak

  DURING OPERATION OF LEFT THIGH AVBG, DOCTOR USED R06050 (LOT: LVG1654) . DOCTOR FOUND THE GRAFT WAS PERMEABLE ONLY ONE SIDE WHICH PTFE GRAFT BRIDGE TO ARTERY NEAR GROIN AREA., SHE THEN PUT DRAIN TUBE AT THE SWEATING SIDE AND CLOSED THE INCISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5847852 ↗