ProCol Vascular Bioprosthesis HJL016-25-NRecalls & reported problems
Hancock Jaffe Laboratories, Inc. · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00866271000015), received between Nov 3, 2015 and Nov 3, 2015 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Bacterial Infection1
- Cellulitis1
- Staphylococcus Aureus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2015Insufficient Device Problem Information
ON (B)(6) 2015 A PROCOL GRAFT WAS IMPLANTED IN THE LEFT ARM OF A FEMALE PATIENT FOR AV-ACCESS. APPROXIMATELY 4 WEEKS LATER THE PATIENT PRESENTED WITH CELLULITIS OVER THE GRAFT AND DRAINAGE FROM THE INCISION ABOVE THE ELBOW. A SPECIMEN WAS COLLECTED FOR CULTURING AND THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS AND SENT HOME. THE CULTURE CONFIRMED THE PRESENCE OF INFECTION (STAPHYLOCOCCUS AUREUS) AND WHEN THE PATIENT HAD NOT RESPONDED TO THE ANTIBIOTICS AFTER 72 HOURS THE GRAFT WAS EXPLANTED.
Patient problems: Bacterial Infection; Cellulitis; Staphylococcus Aureus
MAUDE report 5199320 ↗
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- 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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