Artegraft Vascular Graft AG 730Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00316837000275), received between Aug 30, 2016 and Mar 18, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Packaging Compromised” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2022Obstruction of Flow; Obstruction of Flow

  THE SALES REPRESENTATIVE ATTENDED A CASE ON (B)(6) 2022 AT (B)(6) GENERAL HOSPITAL. THE SURGEON USED A VIABHAN STENT TO CONNECT ARTEGRAFT COLLAGEN VASCULAR GRAFT ON THE VENOUS SIDE AND SUTURED THE ARTERIAL SIDE. PATIENT WAS DISCHARGED AS PLANNED. THE SALES REPRESENTATIVE FOLLOWED UP WITH THE SURGEON ON 2/17/2022 AFTER THE POST PROCEDURE FOLLOW-UP (USING DOPLER ULTRASOUND) AND WAS INFORMED THAT THE PATIENTS GRAFT HAD THROMBOSED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13807119 ↗
• MalfunctionOct 17, 2017Leak/Splash; Leak/Splash

  ARTEGRAFT INC. RECEIVED AN EMAIL COMMUNICATION FROM AN AUTHORIZED DISTRIBUTOR THAT AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) WAS IDENTIFIED AS LEAKING DURING THE PRE-IMPLANT PRESSURE TESTING PER THE CORRESPONDING ARTEGRAFT IFU. THE SURGEON NOTED THAT THE GRAFT APPEARED TO HAVE A SMALL 1 MM HOLE IN IT AND WAS LEAKING IN THE MIDDLE OF THE GRAFT, NOT NEAR A BRANCH. THE SURGEON WAS ABLE TO REPAIR THE GRAFT HOLE WITH 6.0 PROLENE SUTURE AND THE GRAFT (LOT: 17A008-009) WAS SUCCESSFULLY IMPLANTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6955649 ↗
• MalfunctionAug 30, 2016Device Packaging Compromised; Device Packaging Compromised

  ARTEGRAFT (COLLAGEN VASCULAR GRAFT) LOT 15H214-004 WAS RECEIVED IN THE MAIL WITH A PACKING SLIP FROM (B)(4) (ARTEGRAFT APPROVED DISTRIBUTOR) STATING THAT ON (B)(6) 2015 A RN WENT TO OPEN THE TUBE AND THE SEAL WAS LEAKING, SO DIDN'T FEEL COMFORTABLE USING IT. IT ALSO STATES THAT THE BOX WAS SEALED. A SECOND ARTEGRAFT (COLLAGEN VASCULAR GRAFT) WAS UTILIZED ON THE PATIENT INSTEAD. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5914110 ↗