ProxiCor for Cardiac Tissue Repair CMCV-067-404Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859389005058), received between Aug 17, 2016 and Jun 1, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Delamination” (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 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  A MITRAL VALVE REPLACEMENT WAS COMPLETED ON A (B)(6) YEAR OLD MALE ON (B)(6) 2017 WITH USE OF ECM PATCHES THAT WAS SOAKED IN SALINE (SOAK TIME UNKNOWN). IT WAS REPORTED THAT THE PATIENT DEVELOPED A COUGH APPROXIMATELY A WEEK AFTER THE PROCEDURE. IN (B)(6) 2017 (SPECIFIC DATE UNKNOWN) A THORACENTESIS WAS COMPLETED AND FLUID WAS REMOVED FROM CHEST AREA. ON (B)(6) 2017 A CHAMBERLAIN PROCEDURE WAS COMPLETED AND IT WAS REPORTED THAT APPROXIMATELY 2/3 OF THE PATCH WAS REMOVED (SPECIFIC DETAILS ARE UNKNOWN). IT WAS REPORTED THAT THE POCKET OF FLUID WAS NOT A HEMATOMA BUT RATHER TURBID FLUID WITH NO INFECTION PRESENT (BASED FROM HOSPITAL PATHOLOGY).

  Patient problems: Reaction; Unspecified Infection

  MAUDE report 7561925 ↗
• MalfunctionAug 17, 2016Delamination; Material Deformation; Delamination; Material Deformation

  IT WAS REPORTED ON JULY 19, 2016 THAT THE CORMATRIX ECM FOR CARDIAC TISSUE REPAIR 4CM X 7CM (CMCV-004-404, LOT#M16B1041) WAS GOING TO BE USED AS A MAIN PULMONARY ARTERY PATCH. WHEN PACKAGING WAS OPENED, THE ECM MATERIAL (DRY) WAS "THICKER THAN NORMAL AND FELT CUSHIONY, LIKE A MATTRESS". ECM MATERIAL WAS THEN HYDRATED AND AT THE TIME OF USE MATERIAL STARTED TO DELAMINATE ALMOST IMMEDIATELY. ADDITIONAL INFORMATION RECEIVED ON JULY 26, 2016 STATES THAT THE DOCTOR DID IMPLANT THE ECM MATERIAL AFTER CUTTING OUT THE PORTION THAT APPEARED TO HAVE DELAMINATED. AS OF TODAY, THERE IS NO ADDITIONAL INFORMATION. IF AND WHEN ADDITIONAL INFORMATION IS RECEIVED, THE FILE WILL BE UPDATED ACCORDINGLY. A REVIEW OF THE DHR AND SUBLOTS SHOWS THAT THERE WERE NO CONTRIBUTING ISSUES TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5881839 ↗