Artegraft Vascular Graft AG 636Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00316837000237), received between Sep 17, 2015 and Apr 20, 2021 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  A LEMAITRE SALES REPRESENTATIVE RECEIVED AN EMAIL NOTIFICATION FROM THE HOSPITAL STATING "RECENTLY THE STAFF WAS OPENING AN AG636 ARTEGRAFT FOR A CASE AND THEY SAID IT WAS LEAKING AND THE BALLOON DID NOT INFLATE. FROM MY UNDERSTANDING IT WAS NOT IMPLANTED IN THE PATIENT." NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697296 ↗
• 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 1 OF 2. ON (B)(6) 2017 THE PATIENT HAD FEMORODISTAL BYPASS SURGERY WITH TWO 5MM ARTEGRAFTS. THE BYPASS "WENT DOWN" AND THE PATIENT ENDED UP IN ANOTHER FACILITY BEFORE COMING BACK TO DR. (B)(6). WHEN THE PATIENT PRESENTED TO HIM ROUGHLY 2 WEEKS POST-OP, SHE HAD PSEUDOMONAS. THE SURGEON MENTIONED THAT THE GRAFT "DISSOLVED" IN A PORTION WHERE IT WAS INFECTED AND HAD A "BIG HOLE" IN IT. THE PATIENT REPORTEDLY EXPIRED AND IT WAS STATED THAT IT WAS "NOT DUE TO THE ARTEGRAFT".

  Patient problems: Hematoma; Post Operative Wound Infection

  MAUDE report 7247266 ↗
• InjuryFeb 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ARTEGRAFT, INC. RECEIVED AN EMAIL FROM AN APPROVED DISTRIBUTOR REPRESENTATIVE ON BEHALF OF A VASCULAR SURGEON ((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 1 OF 2. ON (B)(6) 2017 THE PATIENT HAD FEMORODISTAL BYPASS SURGERY WITH TWO 5 MM ARTEGRAFTS. THE BYPASS "WENT DOWN" AND THE PATIENT ENDED UP IN ANOTHER FACILITY BEFORE COMING BACK TO DR. WEISS. WHEN THE PATIENT PRESENTED TO HIM ROUGHLY 2 WEEKS POST-OP SHE HAD PSEUDOMONAS. THE SURGEON MENTIONED THAT THE GRAFT "DISSOLVED" IN A PORTION WHERE IT WAS INFECTED AND HAD A "BIG HOLE" IN IT. THE PATIENT REPORTEDLY EXPIRED AND IT WAS STATED THAT IT WAS "NOT DUE TO THE ARTEGRAFT".

  Patient problems: Hematoma; Post Operative Wound Infection

  MAUDE report 7247260 ↗
• MalfunctionJun 1, 2016Break; Break

  AN APPROVED DISTRIBUTOR REPORTED ON BEHALF OF THE VASCULAR SURGEON THAT DURING THE TUNNELING PROCEDURE OF GRAFT IMPLANTATION, THE ARTEGRAFT (COLLAGEN VASCULAR GRAFT) "BROKE". THE SURGERY WAS ABLE TO BE COMPLETED USING A SECOND ARTEGRAFT DEVICE. DETAILS OF THE PROCEDURE WERE REQUESTED BY ARTEGRAFT; HOWEVER, TO DATE WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5692931 ↗
• InjurySep 17, 2015Leak/Splash

  DURING A VISIT WITH ARTEGRAFT EXECUTIVE MANAGEMENT, THE DOCTOR REPORTED A RECENT ISSUE WITH AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) THAT DEVELOPED A SEROMA AROUND THE GRAFT AFTER BEING IMPLANTED. ON (B)(6) 2015 THE PRIMARY ARTEGRAFT WAS IMPLANTED IN THE PATIENT'S RIGHT LEG. IT IS REPORTED THAT THE GRAFT WAS PRESSURE TESTED AND FLUSHED PRIOR TO USE PER THE IFU. SEROMA HAD DEVELOPED AROUND THE GRAFT 2 WEEKS AFTER BEING IMPLANTED. ON (B)(6) 2015, THE GRAFT WAS RE-EXPLORED AND THE SEROMA WAS DRAINED. THE PATIENT IS CURRENTLY STABLE AND THE GRAFT IS PATENT. NO LYMPHATIC LEAK OR INFECTION WAS OBSERVED. HOWEVER, AS THE SEROMA RECURRED FOLLOWING DRAINING, THE DOCTOR IS PLANNING TO EXPLANT THE GRAFT (SCHEDULED DATE NOT PROVIDED).

  Patient problems: Seroma

  MAUDE report 5084171 ↗