Artegraft Vascular Graft AG 640Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00316837000244), received between Feb 7, 2018 and Dec 10, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 2, 2025Class IIOpen, Classified

   The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.

   Z-0034-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024

  THE GRAFT WAS SPATULATED AND SEWN INTO THE VEIN USING RUNNING 6-0 PROLENE. AT THE END OF THE PROCEDURE, THE VESSELS AND GRAFT WERE FLUSHED WITH GOOD FLOW. ONE REPAIR STITCH WAS PLACED IN EACH OF THE ARTERIAL AND VENOUS ANASTOMOSES. THERE WAS STRONG FLOW IN THE GRAFT TO THE MIDPORTION OF THE TUNNELED AREA BUT VERY LITTLE FLOW INTO THE VENOUS AREA. THE TUNNEL WAS ENLARGED MANUALLY FROM BOTH DIRECTIONS TO ENSURE THAT THERE WAS NO STRICTURE OF THE GRAFT. THERE WAS NOT. THE GRAFT WAS OPENED, AND A CORONARY DILATOR WAS PASSED THROUGH THE GRAFT AS WAS A FOGARTY BALLOON CATHETER. NO CLOT OR OTHER PROBLEM WAS NOTED. A INCISION WAS MADE OVER THE POINT OF THE PULSE DIFFERENTIAL, AND THE GRAFT WAS NOTED TO BE BRUISED APPEARING. THE GRAFT WAS OPENED, AND A DISSECTION FLAP WAS SEEN WITHIN THE GRAFT. A SMALL PORTION OF THE GRAFT WAS EXCISED AND RE-ANASTOMOSED, BUT THIS DID NOT FIX THE PROBLEM. LEFT OVARY GRAFT MATERIAL FROM THE ORIGINAL TRIMMING OF THE GRAFT WAS THEN USED TO REPLACE MOST OF THE ARTERIAL PORTION OF THE GRAFT. IT WAS SEWN INTO THE VENOUS AREA AT THE COUNTER-INCISION AND WAS SEWN INTO THE ARTERIAL PORTION APPROXIMATELY 2 CM FROM THE ANASTOMOSIS. FOLLOWING THIS, THERE WAS EXCELLENT F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20891711 ↗
• InjuryApr 28, 2021Contamination; Contamination

  THE DOCTOR MENTIONED TO A SALES REPRESENTATIVE THAT HE WOULD NO LONGER BE UTILIZING ARTEGRAFT IN THE GROIN/LEG AS HE HAD 4 PATIENTS IN THE LAST FEW MONTHS THAT GET INFECTED AND THE GRAFT DISINTEGRATED. UPON REVIEW OF THE DETAILS, IT WAS LATER UPDATED THAT ONLY 2 PATIENTS WERE IDENTIFIED AS HAVING ARTEGRAFT IMPLANTED. THE FOLLOWING PATIENT INFORMATION WAS PROVIDED FOR PATIENT 1: LEFT LEG GROOVE AVG UTILIZING AN ARTEGRAFT 5 MM GRAFT ON (B)(6) 2020,· EMERGENT EXPLORATION, LEFT COMMON FEMORAL WITH EXCISION OF AV GRAFT ON (B)(6) 2020. BELOW KNEE AMPUTATION BEFORE THE GRAFT WAS IMPLANTED AND THEN ABOVE KNEE AMPUTATION AFTER THE GRAFT IMPLANT, LIKELY DUE TO THE COMPLICATIONS.

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 11737713 ↗
• MalfunctionApr 24, 2020Material Puncture/Hole; Material Puncture/Hole

  ARTEGRAFT INC. RECEIVED AN EMAIL COMMUNICATION FROM AN AUTHORIZED DISTRIBUTOR THAT AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) WAS IDENTIFIED PRIOR TO IMPLANT AS HAVING A "HOLE". IT WAS ALSO NOTED THAT THE GRAFT "SEEMED THINNER THAN NORMAL". THE SURGEON WAS ABLE TO REPAIR THE GRAFT HOLE WITH SUTURE BUT SUBSEQUENTLY TRIMMED, AND DISPOSED OF THAT PORTION OF THE GRAFT; THE REMAINING GRAFT LENGTH (LOT: 19L318-027) WAS SUCCESSFULLY IMPLANTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9998316 ↗
• InjuryFeb 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ARTEGRAFT, INC. RECEIVED AN EMAIL FROM AN APPROVED DISTRIBUTOR REPRESENTATIVE ON BEHALF OF A VASCULAR SURGEON (DR. (B)(6)) STATING THAT HE RECENTLY HAD 2 PATIENTS THAT ACQUIRED INFECTIONS ROUGHLY 2 WEEKS POST-OP ARTEGRAFT (COLLAGEN VASCULAR GRAFT) IMPLANT FOR PERIPHERAL USE. THIS FILE WILL CAPTURE PATIENT 2 OF 2. ON (B)(6) 2017 THE PATIENT HAD AN ARTEGRAFT IMPLANTED FOR FEMORAL POPLITEAL AT THE RIGHT KNEE. THE PATIENT PRESENTED TO THE ER AT (B)(6) ON (B)(6) 2017 WITH INFECTION, FEVER, SEVERELY SEPTIC AND TESTED POSITIVE FOR MULTIPLE INFECTIONS AT DISTAL/PROXIMAL END OF GRAFT. AFTER 2 DAYS ((B)(6) 2017) THE PATIENT WAS TRANSFERRED TO (B)(6) TO DR. (B)(6) FOR SURGERY. ON (B)(6) 2017 DR. (B)(6) DICTATION SAYS: INCISION, DRAINAGE AND WASHOUT OF RIGHT LOWER EXTREMITY THIGH AND GROIN. APPLIED WOUND VAC. ANTIBIOTIC BEAD PLACEMENT RIGHT THIGH AND GROIN. RIGHT THIGH MUSCLE FLAP COVERAGE OF GRAFT. INFECTION SPECIES WAS NOT NOTED. NO INFORMATION WAS PROVIDED REGARDING STATUS OF GRAFT AFTER THE PATIENT WAS TRANSFERRED BACK TO THE NURSING HOME. NO NOTES OF GRAFT FAILURE. PATIENT IS REPORTEDLY BACK AT THE HOSPITAL FOR "OTHER REASONS".

  Patient problems: Post Operative Wound Infection

  MAUDE report 7247267 ↗