EDWARDS BOVINE PERICARDIAL PATCH 4700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103144178), received between Feb 4, 2021 and Apr 2, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 4700 PERICARDIAL PATCH WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 27 DAYS DUE TO UNKNOWN REASON. REPORTEDLY, PATIENT WAS IN RECOVERY POST-OPERATIVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24767807 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EDWARDS LEARNED THROUGH VOLUNTARY MEDWATCH REPORTING OF AN EVENT INVOLVING A 4700 BOVINE PERICARDIAL PATCH EVENT REPORTING THE FOLLOWING: PATIENT HAD LV TO AORTA BAFFLE WITH RV TO PA CONDUITS, PULMONARY VENOUS TO R ATRIUM BAFFLE WITH AUGMENTATION OF SVC AND IVC 2021 AND L AV VALVE AND AORTIC VALVE REPLACEMENT 2022. WHEN A BERLIN VAD WAS PLACED 2022, A LARGE MASS WAS NOTED INFILTRATING INTO VESSEL WALL THAT WAS IDENTIFIED AS ASPERGILLUS FLAVUS. CONCERN FOR PRODUCT CONTAMINATION.

  Patient problems: Endocarditis; Fungal Infection

  MAUDE report 15026428 ↗
• MalfunctionFeb 4, 2021Fluid/Blood Leak; Leak/Splash; Tear, Rip or Hole in Device Packaging; Fluid/Blood Leak; Leak/Splash; Tear, Rip or Hole in Device Packaging

  EDWARDS RECEIVED INFORMATION THAT GLUTARALDEHYDE SOLUTION LEAKAGE WAS FOUND FROM THE JAR CRACK PRIOR TO USE WHEN A DISTRIBUTOR REPRESENTATIVE BROUGHT THE DEVICE TO THE HOSPITAL. THERE WAS NO PATIENT/USER COMPLICATION REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11283146 ↗