Artegraft Vascular Graft AG 735Recalls & reported problems
Lemaitre Vascular, Inc. · 6mm x 35 cm · Class 3 · Implant
All models of Artegraft Vascular Graft (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00316837000282), received between Jan 7, 2022 and Jan 7, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- 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
Device problems
- Material Integrity Problem1
Patient problems
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2022Material Integrity Problem; Material Integrity Problem
PATIENT HAD A LEFT ARM BRACHIAL ARTERY TO BRACHIAL VEIN ARTEGRAFT IMPLANTED (B)(6) 2021. ON (B)(6) 2021, IT WAS REPORTED CLOTTED BY THE DIALYSIS CENTER SO THE DOCTOR PERFORMED A THROMBECTOMY AND PULLED OUT THE CLOT FROM THE ARTERIAL END. THE GRAFT WAS SUCCESSFULLY ACCESSED 3-5 TIMES. ON (B)(6) 2021 IT WAS AGAIN CLOTTED AND THE DOCTOR PERFORMED A SECOND THROMBECTOMY/EXPLORATION AND AGAIN FOUND A CLOT ON THE ARTERIAL END. THE DOCTOR STATED THAT IT LOOKED LIKE ACCESS SITES WERE CLOSER TO THIS END OF GRAFT. VENOUS END WAS OPEN. DURING THE PROCEDURE THE DOCTOR WAS ABLE TO SEE THAT THE MID PORTION OF THE GRAFT LOOKED LIKE THE WALLS OF GRAFT HAD SEPARATED. HE SAID IT APPEARED THAT THE INTIMAL WALL WAS JUST" FREE-FLOATING" LIKE A STRAW WITHIN THE LUMEN OF THE GRAFT. HE WAS WORRIED THAT THE GRAFT WAS FAULTY SO HE LIGATED THE GRAFT. THE PATIENT CONTINUES DIALYSIS ON A CATHETER NOW AND WILL HAVE A NEW GRAFT IMPLANTED IN (B)(6).
Patient problems: Thrombosis/Thrombus
MAUDE report 13196877 ↗
Other Tissue Graft Of 6mm And Greater devices
- Artegraft Vascular Graft AG 740Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater2 recalls5 reports
- Artegraft Vascular Graft AG 1015Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater2 recalls0 reports
- Artegraft Vascular Graft AG 636Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall5 reports
- Artegraft Vascular Graft AG 640Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall4 reports
- Artegraft Vascular Graft AG 730Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall3 reports
- Artegraft Vascular Graft AG 630Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall2 reports
- Artegraft Vascular Graft AG 750Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall2 reports
- Artegraft Vascular Graft AG 745Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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