ProCol Biologic Vascular Graft HJL016-30-NRecalls & reported problems
Lemaitre Vascular, Inc. · ProCol Biologic Vascular Graft, 6mm x 30 cm · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840663108671), received between Sep 28, 2022 and Sep 28, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
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.
Most reported problems
Device problems
- Material Puncture/Hole1
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.
MalfunctionSep 28, 2022Material Puncture/Hole; Material Puncture/Hole
ACCORDING TO THE SURGEON, A PROCOL VASCULAR BIOPROSTHESIS WAS BEING PREPARED FOR USE AND A HOLE IN THE GRAFT WAS FOUND WHEN THEY OPENED THE PACKAGE. THE CONTAINER WAS STILL SEALED WHEN THE HOLE WAS OBSERVED AND THE PRODUCT WAS NOT USED ON THE PATIENT. THE PRODUCT WAS DISCARDED BY THE HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15498800 ↗
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
- 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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