ProCol Biologic Vascular Graft HJL016-40-NRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00840663108688), received between Sep 22, 2016 and Feb 19, 2020 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (7 reports).

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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2020Structural Problem

  SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS IN A DIALYSIS PATIENT. AFTER COMPLETION OF ARTERIAL ANASTOMOSIS, WHEN SURGEON REMOVED THE CLAMP AND THE GRAFT WAS UNDER ARTERIAL PRESSURE, HE OBSERVED THE PROXIMAL END OF THE GRAFT HAD DILATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9729589 ↗
• MalfunctionOct 18, 2019Material Integrity Problem; Material Integrity Problem

  SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS TO A DIALYSIS PATIENT. AFTER SURGEON COMPLETED THE ARTERIAL ANASTOMOSIS, UPON PRESSURIZING THE GRAFT, HE OBSERVED ANEURYSMAL SPOT AT TWO DIFFERENT SUTURE TIES IN THE GRAFT. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: Aneurysm

  MAUDE report 9209471 ↗
• MalfunctionOct 16, 2019Material Integrity Problem; Material Integrity Problem

  SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS TO A DIALYSIS PATIENT. AFTER SURGEON COMPLETED THE ARTERIAL ANASTOMOSIS, UPON PRESSURIZING THE GRAFT, HE OBSERVED ANEURYSMAL SPOT AT THREE DIFFERENT SUTURE TIES IN THE GRAFT.

  Patient problems: Aneurysm

  MAUDE report 9198734 ↗
• MalfunctionOct 11, 2019Material Integrity Problem; Material Integrity Problem

  SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS TO A DIALYSIS PATIENT. AFTER SURGEON COMPLETED THE ARTERIAL ANASTOMOSIS, UPON PRESSURIZING THE GRAFT, HE OBSERVED AN ANEURYSMAL SPOT ON THE GRAFT. SURGEON REPAIRED THE GRAFT AND CONTINUED WITH THE SURGERY. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182637 ↗
• MalfunctionOct 11, 2019Material Integrity Problem; Material Integrity Problem

  WHILE RINSING THE GRAFT, SURGEON NOTICED A THIN WALL SPOT ON THE GRAFT NEXT TO THE SUTURE TIE. THE GRAFT ALSO APPEARED TO BE ANEURYSMAL AT THE REGION OF THE SUTURE TIE. GRAFT WAS NOT IMPLANTED.

  Patient problems: Aneurysm

  MAUDE report 9181236 ↗
• MalfunctionOct 7, 2019Material Integrity Problem; Material Integrity Problem

  SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS TO A DIALYSIS PATIENT. AFTER SURGEON COMPLETED THE ARTERIAL ANASTOMOSIS, UPON PRESSURIZING THE GRAFT, HE OBSERVED MULTIPLE KINKS ON THE GRAFT. HE STATED THAT THE SUTURES WERE TIED DOWN EXTREMELY TIGHT WHICH COULD HAVE CAUSED THE GRAFT TO KINK AT THESE SPOTS. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9163916 ↗
• MalfunctionOct 7, 2019Material Integrity Problem; Material Integrity Problem

  SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS TO A DIALYSIS PATIENT. AFTER SURGEON COMPLETED THE ARTERIAL ANASTOMOSIS, UPON PRESSURIZING THE GRAFT, HE OBSERVED AN ANEURYSMAL SPOT ON THE GRAFT. SURGEON REPAIRED THE GRAFT AND CONTINUED WITH THE SURGERY. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9163915 ↗
• MalfunctionSep 13, 2019Material Integrity Problem; Material Integrity Problem

  SURGEON USED A PROCOL VASCULAR BIOPROSTHESIS FOR CREATING A BRIDGE GRAFT FOR VASCULAR ACCESS TO A DIALYSIS PATIENT. AFTER SURGEON COMPLETED THE ARTERIAL ANASTOMOSIS, UPON PRESSURIZING THE GRAFT, HE OBSERVED AN ANEURYSMAL SPOT ON THE GRAFT. SURGEON TRIMMED A DISTAL END OF THE GRAFT AND USED IT TO PATCH THIS SPOT. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9047333 ↗
• MalfunctionMar 22, 2019Device Damaged Prior to Use

  DURING PRE-USE CHECK, SURGEON OBSERVED THE DISTAL SECTION OF THE GRAFT TO HAVE DILATED.

  Patient problems: No Patient Involvement

  MAUDE report 8445484 ↗
• InjuryOct 31, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE GRAFT DILATED AT THE ARTERIAL END ONCE THE BLOOD FLOW WAS INTRODUCED INTO THE GRAFT AFTER PERFORMING THE ARTERIAL ANASTOMOSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8025977 ↗
• InjuryJan 12, 2018Occlusion Within Device; Occlusion Within Device

  THE PROCOL VASCULAR BIOPROSTHESIS GRAFT WAS PLACED IN THE LOWER RIGHT ARM FOR AV ACCESS. AFTER THREE WEEKS OF IMPLANT, WHEN DOCTOR ATTEMPTED TO DECLOT THE GRAFT, HE FOUND THAT THE GRAFT HAD OCCLUDED AT THE APEX OF THE GRAFT. HE ALSO FOUND A HOLE IN THE GRAFT. SO, HE SEWED BOTH ENDS AND ABANDONED THE GRAFT.

  Patient problems: Failure of Implant; Occlusion

  MAUDE report 7187515 ↗
• MalfunctionDec 27, 2016Fluid/Blood Leak; Fluid/Blood Leak

  WHEN THE SURGICAL TECH WAS FLUSHING THE GRAFT, HE NOTICED THE GRAFT WAS LEAKING FROM THE MIDPOINT OF THE GRAFT. SO, HE CLAMPED THE DISTAL END AND LIGHTLY FLUSHED THE GRAFT, WHICH THEN SHOWED DIFFUSE WEEPING FROM MULTIPLE AREAS. NO OBVIOUS DEFECT WAS NOTED. THE GRAFT WAS THEN DISCARDED AND THEN ANOTHER GRAFT WAS USED. THE GRAFT WAS NOT USED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6207935 ↗
• MalfunctionSep 22, 2016Fluid/Blood Leak; Physical Property Issue; Fluid/Blood Leak; Physical Property Issue

  DURING IMPLANTATION OF THE GRAFT, THE SURGEON PRESSURIZED IT AND NOTICED THAT A ONE INCH SECTION NEAR THE END APPEARED THIN, LIGHTER IN COLOR AND STARTED TO SLIGHTLY LEAK. THE DOCTOR REMOVED THE GRAFT AND USED A DIFFERENT GRAFT IN STOCK WITHOUT FURTHER INCIDENT.

  Patient problems: No Information

  MAUDE report 5970207 ↗