Artegraft Vascular Graft AG 1015Recalls & reported problems
Lemaitre Vascular, Inc. · 8mm x 15 cm · Class 3 · Implant
All models of Artegraft Vascular Graft (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- Sep 25, 2025Class IIOpen, Classified
The device was incorrectly packed in the wrong size labeled outer packaging.
Z-0289-2026 · Root cause: Packaging change control · Recall details · FDA record ↗
- 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 ↗
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 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
- Artegraft Vascular Graft AG 616Lemaitre Vascular, Inc. · Tissue Graft Of 6mm And Greater1 recall1 report
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
- 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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