CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFX (REF 2700TFX19MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103194012), received between Feb 22, 2022 and Feb 20, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 19MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, THREE (3) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INSPIRIS VALVE. 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 24405253 ↗
• InjuryFeb 13, 2025Degraded; Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 19MM 2700TFX AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, ELEVEN (11) MONTHS DUE TO DEGENERATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED ON POD #8. 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: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 21378690 ↗
• InjuryFeb 22, 2022Degraded; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem; Degraded; Gradient Increase; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 2700TFX 19MM BIOPROSTHETIC AORTIC VALVE, IMPLANTED FOR TWO (2) YEARS AND SIX (6) MONTHS, WAS EXPLANTED DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH AN 11500A 19MM INSPIRIS RESILIA VALVE. PATIENT POST PROCEDURE IN RECOVERY. THE IMPLANTATION DATA CARD INDICATED THAT THE DEVICE EXPLANT WAS NOT DUE TO DEFICIENCY OF THE ORIGINAL DEVICE. 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: Dyspnea; Endocarditis; Insufficient Information

  MAUDE report 13581819 ↗