Artegraft Vascular Graft AG 616Recalls & reported problems
Lemaitre Vascular, Inc. · 5mm x 16 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 00316837000213), received between Jan 10, 2024 and Jan 10, 2024 — classified as 1 malfunction.
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.
Reports received per month
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
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 10, 2024
GRAFT APPEARED MUCH SMALLER THAN STATED ON PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484423 ↗
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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