Artegraft Vascular Graft AG 630Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00316837000220), received between Mar 22, 2016 and Mar 22, 2016 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2016Device Packaging Compromised; Device Packaging Compromised

  ARTEGRAFT INC. RECEIVED AN EMAIL COMMUNICATION FROM AN AUTHORIZED DISTRIBUTOR (WHO WAS PRESENT WITH THE DOCTOR DURING THE PROCEDURE) ON BEHALF OF THE HOSPITAL, THAT AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) STORAGE TUBE APPEARED TO HAVE LEAKED STORAGE LIQUID, AS "THE LABEL ON THE TUBE WAS SMEARED AND THE LEVEL OF FLUID IN THE BOTTLE WAS LOW". UPON FOLLOW UP COMMUNICATIONS, THE DISTRIBUTOR STATED THAT THE STORAGE TUBE WAS REMOVED FROM THE SEALED PACKAGE AT THE HOSPITAL AND IT WAS NOTICED THAT THE RED ARTEGRAFT LOGO ON THE STORAGE TUBE LABEL APPEARED TO BE "SMEARED". ALSO, THE TAMPER SLEEVE WAS STILL INTACT AND THE VOLUME OF STORAGE LIQUID IN THE TUBE WAS SLIGHTLY LESS THAN PREVIOUSLY SEEN WITH OTHER ARTEGRAFT PRODUCTS; THE CAP SEEMED TO BE AS TIGHT AS OTHER GRAFTS PREVIOUSLY OPENED. IT WAS CONFIRMED THAT THE HOSPITAL STORES THE PRODUCT STANDING UPRIGHT WITH THE LABEL END UP RATHER THAN LYING FLAT, LENGTHWISE. IT WAS ALSO STATED THAT WHEN COMPARED SIDE BY SIDE TO ANOTHER GRAFT WITH THE SAME PRODUCT CODE, THE GRAFT INNER DIAMETER APPEARED "MUCH SMALLER" THAN THE SIZE ON THE LABEL (5 MM ID) OR THE SECOND GRAFT INNER DIAMETER MAY HAVE BEEN LARGER THAN 5 MM. THIS GRAFT WAS IMPLANTED AND THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5517753 ↗
• MalfunctionMar 22, 2016Leak/Splash; Leak/Splash

  ARTEGRAFT INC. RECEIVED AN EMAIL COMMUNICATION FROM AN AUTHORIZED DISTRIBUTOR (WHO WAS PRESENT WITH THE DOCTOR DURING THE PROCEDURE) THAT AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) WAS IDENTIFIED AS LEAKING DURING THE PRE-IMPLANT PRESSURE TESTING PER THE CORRESPONDING ARTEGRAFT IFU. UPON FOLLOW UP COMMUNICATIONS, THE DISTRIBUTOR STATED THAT NO HOLE WAS VISIBLE BUT RATHER IT APPEARED THAT THE GRAFT WALL WAS "LEAKING AND THINNER THAN USUAL". IT WAS ALSO STATED THAT WHEN COMPARED SIDE BY SIDE, EITHER THE GRAFT INNER DIAMETER MAY HAVE BEEN LARGER, OR ANOTHER GRAFT'S INNER DIAMETER WAS "MUCH SMALLER" THAN THE SIZE ON THE LABEL (5 MM ID). THIS GRAFT WAS NOT IMPLANTED. ANOTHER ARTEGRAFT (AG630 PRODUCT CODE) WAS UTILIZED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5517739 ↗