CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS 2800TFX (REF 2800TFX23MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00690103194098), received between Apr 27, 2021 and Sep 5, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 23MM 2800TFX AORTIC VALVE IMPLANTED IN PULMONARY POSITION FOR EIGHT (8) YEARS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE PULMONARY STENOSIS AND MODERATE REGURGITATION. IT WAS REPORTED PATIENT HAD MINIMAL SYMPTOMS DUE TO DIGEORGE DEVELOPMENTAL DELAY, MODERATE TO SEVERE RV DILATION INDICATION. TPVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22983317 ↗
• InjuryAug 8, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, ONE (1) MONTH DUE TO CALCIFICATION WITH MODERATE STENOSIS. THE PATIENT INITIALLY PRESENTED WITH DYSPNEA. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE CASE WENT WELL AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Dyspnea

  MAUDE report 22746624 ↗
• InjuryJun 25, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 2800TFX AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 25MM 11500A RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS. 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 22333016 ↗
• InjuryJan 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER 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 21218920 ↗
• InjuryDec 26, 2024Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2800TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, ONE (1) MONTH DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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: Dyspnea; Insufficient Information

  MAUDE report 21019662 ↗
• InjuryDec 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF SIX (6) YEARS, SEVEN (7) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A 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 20834662 ↗
• InjuryOct 8, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 2 MONTHS DUE TO CALCIFICATION WITH STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11060A VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT REDO-AVR WITH 21MM 11060A VALVED CONDUIT AND MVR WITH A 27MM 11400M VALVE. INTRAOPERATIVELY, AFTER THE HEART WAS REPERFUSED, THERE WAS SIGNIFICANT VOLUME LOSS FROM THE RETROPERITONEUM. VASCULAR SURGERY WAS PERFORMED ALONG WITH DECOMPRESSIVE LAPAROTOMY. CONTINUED ATTEMPTS AT RESUSCITATION WERE UNSUCCESSFUL. THE PATIENT EXPIRED IN THE OR.

  Patient problems: Insufficient Information

  MAUDE report 20398791 ↗
• InjuryMay 21, 2024Device Stenosis; Device Stenosis

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A PATIENT WITH A 23MM 2800TFX AORTIC VALVE IMPLANTED SEVEN (7) YEARS, THREE (3) MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS IN RECOVERY IN ICU AT THE END OF THE PROCEDURE. 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

  MAUDE report 19367271 ↗
• InjuryOct 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 6 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS RESILIA 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 17933478 ↗
• InjurySep 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED A 23MM 2800TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, FIVE (5) MONTHS DUE TO RECURRENT ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 3300TFX VALVE. PER MEDICAL RECORDS, PATIENT HAD PREVIOUSLY BEEN HOSPITALIZED FOR BACTEREMIA SECONDARY TO RECURRENT LLE OSTEOMYELITIS (PSEUDOMONAS AERUGINOSA) ON (B)(6) AND WAS TREATED WITH IV ANTIBIOTICS FOR MANY WEEKS. PATIENT WAS ALSO FOUND TO HAVE BILATERAL SUBACUTE CEREBELLAR INFARCTS DUE TO ENDOCARDITIS. THE PATIENT UNDERWENT REDO-AVR WITH A 21MM 3300TFX VALVE. POST BYPASS TEE SHOWED NO PVL. THE PATIENT WAS STABLE WHEN TRANSPORTED TO THE INTENSIVE CARE UNIT AND WAS DISCHARGED ON POD#7. PATHOLOGY REPORT CONFIRMED VEGETATION, CALCIFICATIONS, AND THROMBOSIS.

  Patient problems: Insufficient Information

  MAUDE report 17809134 ↗
• InjurySep 12, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 5 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A NON-EDWARDS DEVICE. THE PATIENT IS STABLE.

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

  MAUDE report 17731047 ↗
• InjuryJul 24, 2023Gradient Increase; Difficult to Open or Close; Device Stenosis; Gradient Increase; Difficult to Open or Close; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, SEVEN (7) MONTHS DUE TO AORTIC STENOSIS WITH AN APPROXIMATE GRADIENT OF 50MMHG. TWO LEAFLETS WERE NOTED TO BE NONFUNCTIONAL. THE PATIENT INITIALLY PRESENTED WITH DYSPNEA, FATIGUE AND SYNCOPE. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Fatigue; Syncope/Fainting

  MAUDE report 17376888 ↗
• InjuryMay 31, 2023Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX YEARS AND SEVEN MONTHS DUE TO STENOSIS OF THE BIOPROSTHETIC VALVE. THE PATIENT WAS IN CONGESTIVE HEART FAILURE WITH SHORTNESS OF BREATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 23MM 9750TFX VALVE. THIS IS AN 85-Y-O MALE.

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

  MAUDE report 17032149 ↗
• InjuryMay 30, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE IMPLANT FOR 6 YEARS, 4 MONTHS IS UNDER EVALUATION FOR A VALVE-IN-VALVE DUE TO SEVER AORTIC REGURGITATION. THE PATIENT PRESENTS WITH ACUTE ON-CHRONIC HEART FAILURE. THE PROCEDURE HAS NOT YET BEEN PERFORMED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17019932 ↗
• InjuryJun 3, 2022Degraded; Fluid/Blood Leak; Degraded; Fluid/Blood Leak

  IT WAS REPORTED THAT A 23MM PERICARDIAL AORTIC VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 8 MONTHS DUE TO SEVERE REGURGITATION AND EARLY DEGENERATION. THE PATIENT PRESENTED WITH CHRONIC DIASTOLIC HEART FAILURE. THE SURGICAL VALVE WAS FRACTURED AND A 20MM TRANSCATHETER VALVE WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON POD #3.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 14594766 ↗
• InjuryOct 1, 2021Fluid/Blood Leak; Perivalvular Leak; Detachment of Device or Device Component; Insufficient Device Problem Information; Fluid/Blood Leak; Perivalvular Leak; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE IMPLANTED FOR 2 YEARS 8 MONTHS UNDERWENT REDO AORTIC VALVE REPLACEMENT DUE TO UNKNOWN REASONS. A 25MM 11500A AORTIC VALVE WAS IMPLANTED IN REPLACEMENT. PATIENT IN RECOVERY. NO OTHER DETAILS PROVIDED. PER IDC PROSTHESIS WAS REMOVED NOT DUE TO DEFICIENCY. 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; Insufficient Information

  MAUDE report 12566128 ↗
• InjuryJun 18, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  EDWARDS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM VALVE, IMPLANTED IN PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 13 YEARS, FOUR (4) MONTHS DUE TO INSUFFICIENCY AND STENOSIS. THE PATIENT PRESENTED WITH FATIGUE AND SHORTNESS OF BREATH WITH ACTIVITY. THE TPVR WAS PERFORMED WITH A 26MM TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON POD #1. THERE IS NO INVESTIGATIONAL EVIDENCE SUGGESTING THE SURGICAL VALVE FAILED PREMATURELY.

  Patient problems: Dyspnea

  MAUDE report 12028747 ↗
• InjuryApr 27, 2021Perivalvular Leak; Perivalvular Leak

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800TFX AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, SEVEN (7) MONTHS DUE TO PVL.

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

  MAUDE report 11733309 ↗