CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTIC 2800TFX (REF 2800TFX21MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00690103194081), received between Feb 4, 2021 and Aug 29, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2800TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, SIX (6) MONTHS DUE TO CALCIFICATION, DEGENERATION, AND INCREASED/HIGH GRADIENT. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE SECONDARY TO VALVE DISEASE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 20MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22925538 ↗
• InjuryApr 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2800TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FOUR (4) MONTHS DUE TO PATIENT PROSTHESIS MISMATCH. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS VALVE. THE PATIENT WAS NOTED TO BE DOING GREAT POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 21776001 ↗
• InjurySep 13, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2800TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, 10 MONTHS DUE TO STENOSIS AND CALCIFICATION. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE AND AWAKE POST PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 20216417 ↗
• InjuryAug 22, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 21MM 2800TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 7 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, DOE, AND BLE EDEMA. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED POD #2. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH HEART FAILURE CHARACTERIZED BY WORSENING SOB, DOE, CENTRAL CHEST PRESSURE, AND SLOWLY WORSENING SWELLING IN BOTH LEGS. ECHO ((B)(6) 2023) REVEALED A NORMALLY FUNCTIONING 21MM EDWARDS VALVE WITH MILD INTRAVALVULAR REGURGITATION. THE PATIENT WAS DISCHARGED POD #2.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 20026801 ↗
• InjuryApr 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 21MM 2800TFX VALVE IN THE AORTIC POSITION WAS EXPLANTED AFTER AND IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE.

  Patient problems: Insufficient Information

  MAUDE report 19106097 ↗
• InjuryJul 10, 2023Difficult to Open or Close; Patient Device Interaction Problem; Device Stenosis; Difficult to Open or Close; Patient Device Interaction Problem; Device Stenosis

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY THAT A MODEL 2800TFX 21MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 23MM VALVE AFTER AN IMPLANT DURATION OF 3 YEARS, 11 MONTHS DUE TO SEVERE PANNUS, RESTRICTING LEAFLET OPENING, LEADING TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH ANGINA AND LIGHTHEADEDNESS. THE PATIENT WAS DISCHARGED HOME ON POD # 6. PER MEDICAL RECORDS: THE PATIENT UNDERWENT CONCOMITANT CABG X1. IT IS NOTED THERE WAS A SIGNIFICANT AMOUNT OF PANNUS OBSERVED ON THE AORTIC VALVE LEAFLETS OF THE 21MM 2800TFX INHIBITING THE LEAFLETS FROM OPENING ESPECIALLY ON THE NON-CORONARY CUSP. THE POST CPB TEE SHOWED IMPROVED CARDIAC FUNCTIONING WITH NO AORTIC REGURGITATION, THERE WAS A SMALL PVL NOTED IN THE AREA OF THE RIGHT CORONARY CUSP THAT DID NOT RESOLVE WITH PROTAMINE. THE PATIENT WAS TRANSFERRED TO ICU FOR FURTHER MONITORING.

  Patient problems: Angina; Presyncope

  MAUDE report 17290360 ↗
• InjuryJan 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH THE IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 21 MM 2800TFX AORTIC VALVE IMPLANTED FOR 3 YEARS, 4 MONTHS UNDERWENT A VALVE-IN-VALVE PROCEDURE DUE TO UNKNOWN REASONS. THE DEVICE WAS REPLACED WITH A 23 MM 9750TFX TRANSCATHETER VALVE. NO OTHER DETAILS PROVIDED. 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 13402974 ↗
• InjuryJan 28, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED FROM IMPLANT PATIENT REGISTRY THAT A 2800TFX 21MM AORTIC VALVE WAS EXPLANTED AND REPLACED WITH A 11500A 23MM AFTER AN IMPLANT DURATION OF 3 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. THE PATIENT WAS IN RECOVERY. 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 13383990 ↗
• InjuryFeb 4, 2021Gradient Increase; Gradient Increase

  THROUGH IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 21MM 2800TFX AORTIC PERICARDIAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, SEVEN (7) MONTHS DUE TO SEVERE AORTIC STENOSIS. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE SUCCESSFULLY. THE PATIENT WAS DISCHARGED HOME ON POD #1 IN STABLE CONDITION. 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: Heart Failure/Congestive Heart Failure

  MAUDE report 11283031 ↗