VasCure for Vascular Repair CMCV-011-606Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859389005126), received between Nov 25, 2015 and Jun 2, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Hole In Material” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ECM FOR VASCULAR REPAIR (CMCV-012-606 LOT M16N1320) WAS USED ON A (B)(6) MALE PATIENT WHO DEVELOPED A "INFECTED RIGHT FEMORAL AREA." THE ECM HAD BEEN SOAKED FOR APPROX. 30 SECONDS AND USED IN A RIGHT FEMORAL ENDARTERECTOMY WITH RIGHT ILIAC STENT UTILIZING A 6.0 PROLENE SUTURE ON (B)(6) 2017. THE PATIENT WAS DISCHARGED. THE PATIENT THEN RETURNED FOR A RE-DO PROCEDURE ON (B)(6) 2017. PER REDACTED MEDICAL RECORDS, ON (B)(6) 2017 THE FOLLOWING PROCEDURES WERE PERFORMED: "ANGIOGRAPHY OF RIGHT FEMORAL AREA PRIOR TO STARTING THE PROCEDURE AND USED FOR CONTROL OF ILIAC ARTERY, EXPLORATION OF RIGHT FEMORAL AREA, DEBRIDEMENT OF ARTERY AND PREVIOUSLY PLACED PATCH DOWN TO THE EXTERNAL ILIAC AND PROFUNDA FEMORAL ARTERY, RIGHT EXTERNAL ILIAC TO PROFUNDA FEMORAL BYPASS USING SUPERFICIAL FEMORAL ARTERY, A SATORIUS FLAP FOR COVERAGE."

  Patient problems: Unspecified Infection

  MAUDE report 6609833 ↗
• InjuryNov 25, 2015Hole In Material; Material Rupture

  ON (B)(6) 2015, CORMATRIX CARDIOVASCULAR BECAME AWARE OF AN EVENT INVOLVING THE USE OF CORMATRIX ECM FOR VASCULAR REPAIR. DETAILS ARE PROVIDED BELOW. IT WAS REPORTED THAT THE CORMATRIX ECM FOR VASCULAR REPAIR WAS USED DURING A FEMORAL ENDARTERECTOMY PROCEDURE AND IMPLANTED ON (B)(6)2015. THE DEVICE WAS HYDRATED IN ROOM TEMPERATURE SALINE FOR APPROXIMATELY 15-30 SECONDS. THE PATIENT WAS CHECKED AT THREE WEEKS POST OP AND EVERYTHING WAS OBSERVED TO BE FINE. ON (B)(6) 2015 THE DEVICE WAS EXPLANTED DUE TO A 2MM HOLE IN THE CENTER OF THE PATCH. SUTURE LINES WERE FOUND TO BE INTACT. THERE WAS NO EVIDENCE OF INFECTION OR PSEUDO ANEURYSM. IT WAS REPORTED THAT THERE WAS A SUPERFICIAL WOUND INFECTION BUT THAT IT WAS AWAY FROM THE PATCH. THE SAMPLE WAS SENT TO HOSPITAL PATHOLOGY AND IT WAS CONFIRMED THAT THERE WAS NO INFECTION. THE FEMORAL WAS PATCHED WITH ANOTHER PRODUCT. THE PATIENT WAS REPORTED AS DOING WELL.

  Patient problems: No Information

  MAUDE report 5250107 ↗