Artegraft Vascular Graft AG 740Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00316837000299), received between Apr 8, 2016 and Apr 3, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

2 FDA recall records name this device's identifier, 2 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. Feb 10, 2026Class IIOpen, Classified

   Labeling mix-up resulting in the incorrect lot outer packaging of product.

   Z-1574-2026 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. 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.

• InjuryApr 3, 2024Material Rupture; Material Rupture

  THE GRAFT WAS ORIGINALLY IMPLANTED BY DR. (B)(6) ON (B)(6) 2023. THE IMPLANT PROCEDURE PERFORMED WAS "FEM POP", LOWER LIMB BYPASS AND THE DEVICE WAS "CHECKED" BEFORE THE PROCEDURE. THE PATIENT COMPLAINED OF PAIN IN R GROIN ON FRIDAY (B)(6) 2024, WAS CLEARED AND SENT HOME. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2024 AND DR. (B)(6) PERFORMED SURGERY TO REPAIR THE RUPTURED GRAFT WITH STENTS. NO PATIENT INJURY OR CURRENT STATUS WAS REPORTED. PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: Rupture

  MAUDE report 19036947 ↗
• MalfunctionOct 22, 2018Leak/Splash; Leak/Splash

  ARTEGRAFT, INC. RECEIVED AN ELECTRONIC IMPLANT USAGE CARD WITH A NOTE STATING "GRAFT IS DEFECTIVE AND WILL BE PICKED UP BY VENDOR FOR EVALUATION". ADDITIONAL INFORMATION WAS RECEIVED FROM AN APPROVED DISTRIBUTOR REPRESENTATIVE ON BEHALF OF A VASCULAR SURGEON (DR. (B)(6)) EXPLAINING THAT THE GRAFT HAD LEAKED DURING THE PRE-IMPLANT PRESSURE TEST PER THE CORRESPONDING ARTEGRAFT, INC. IFU. THE SURGEON DID NOT IMPLANT THE GRAFT (17M381-020). NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7990809 ↗
• MalfunctionJan 11, 2018Physical Property Issue; Physical Property Issue

  RECEIVED A PHONE CALL FROM AN APPROVED DISTRIBUTOR STATING THAT DURING THE IMPLANT OF THE ARTEGRAFT (COLLAGEN VASCULAR GRAFT) A SURGEON HAD "DIFFICULTY SUTURING". IN FOLLOW-UP COMMUNICATIONS IT WAS CLARIFIED THAT THE GRAFT WAS "BLEEDING AFTER EVERY STITCH" EVEN USING 7-0 SIZE SUTURE. THE SURGEON STATED THAT THE GRAFT THICKNESS WAS NOT THE ACCEPTABLE MEASUREMENT; ONE END WAS OK, BUT THE OTHER END WAS "WAY TOO THIN". "THIS CAUSED MAJOR SUTURE HOLE BLEEDING AFTER EVERY STICH." THE SURGEON "OVERSEWED AND THE BLEEDING WAS CONTROLLED". THE IMPLANT WAS COMPLETED AND THE PATIENT WAS STABLE. THE SURGEON HAS SEEN THE PATIENT IN THE OFFICE AFTER THE IMPLANT AND THE "GRAFT IS FUNCTIONING FINE".

  Patient problems: Blood Loss

  MAUDE report 7182202 ↗
• MalfunctionMar 15, 2017Device Packaging Compromised; Device Packaging Compromised

  ARTEGRAFT, INC. RECEIVED AN EMAIL FROM AN AUTHORIZED DISTRIBUTOR STATING, "HAD A CUSTOMER OPEN A GRAFT TO BE IMPLANTED AND SOME OF THE STERILE SOLUTION HAD LEAKED OUT OF THE BOTTLE PRIOR TO BEING OPENED." THE COMPLAINT GRAFT (LOT 15H217-002) WAS NOT UTILIZED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ARTEGRAFT (COLLAGEN VASCULAR GRAFT). NO PATIENT ADVERSE EVENTS RELATED TO THIS ISSUE WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6406072 ↗
• MalfunctionApr 8, 2016Leak/Splash; Leak/Splash

  ARTEGRAFT, INC. RECEIVED A PHONE CALL FROM AN AUTHORIZED DISTRIBUTION CENTER REGARDING AN INCIDENT OF A LEAKING ARTEGRAFT (COLLAGEN VASCULAR GRAFT). UPON FOLLOW-UP DISCUSSIONS WITH THE HOSPITAL'S SALES REPRESENTATIVE, IT WAS STATED THAT THE LEAK (WHICH APPEARED TO BE A TRIBUTARY) WAS IDENTIFIED DURING THE PRE-IMPLANT PRESSURE TESTING; A SUTURE WAS USED BY THE SURGEON TO SEAL THE LEAK. "THE SURGEON WAS CONFIDENT AFTER REPAIRING THE LEAK TO PROCEED WITH IMPLANTING GRAFT." NO ADVERSE EVENTS WERE REPORTED AND THE STATUS OF THE PATIENT WAS REPORTED AS "ALL IS OK".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5563551 ↗