CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFX (REF 2700TFX21MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00690103194029), received between Dec 16, 2022 and Apr 9, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 21MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SIX (6) YEARS, SIX (6) 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: Endocarditis; Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 24832631 ↗
• InjuryApr 8, 2026Patient Device Interaction Problem

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 21 MM 2700 TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS DUE TO MODERATE PANNUS AND SEVERE STENOSIS. THE PATIENT PRESENTED WITH SOB, LIGHTHEADEDNESS, AND CHEST PAIN. THE EXPLANTED VALVE WAS REPLACED WITH A 23 MM 11500A VALVE. THE PATIENT WAS DISCHARGED POD #13. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH INCREASING DYSPNEA, LIGHTHEADEDNESS, AND CHEST DISCOMFORT. IMAGING REVEALED SEVERE AORTIC VALVE STENOSIS CAUSED BY PROSTHETIC THICKENING AND KNOWN MUSCULAR VSD. THE PATIENT UNDERWENT REDO AVR. INTRA-OPERATIVELY, THE PREVIOUS SURGICAL VALVE WAS FOUND TO HAVE SIGNIFICANT OVERLYING PANNUS. THE 21 MM 2700TFX VALVE WAS EXPLANTED. THE AORTIC ROOT WAS ENLARGED USING BOVINE PERICARDIAL PATCH AND PLEDGETTED NON-EVERTING MATTRESS SUTURES. A 23 MM INSPIRIS RESILIA AORTIC VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO COMPLICATIONS. THE PATIENT WAS DISCHARGED POD #13. PER PATHOLOGY REPORT, THE EXPLANTED 21 MM 2700TFX WAS RECEIVED WITH MODERATE PANNUS FORMATION, NO CALCIFICATION, NO VEGETATION, AND NO STRUCTURAL ABNORMALITIES. EDWARDS LIFESCIE

  Patient problems: Dyspnea

  MAUDE report 24821056 ↗
• InjuryDec 23, 2025Insufficient 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 21MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #11.

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

  MAUDE report 23885573 ↗
• InjurySep 12, 2025Thickening of Material; Thickening of Material

  IT WAS REPORTED THAT A PATIENT WITH A 35MM 6625 PORCINE MITRAL VALVE IN THE TRICUSPID POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO LEAFLETS THICKENING WITH SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND FATIGUE. TTVR WAS COMPLETED WITH A 29MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Fatigue; Heart Failure/Congestive Heart Failure

  MAUDE report 23038791 ↗
• InjuryAug 6, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700TFX AORTIC VALVE IS UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS AND 11 MONTHS DUE TO UNKNOWN REASON.

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

  MAUDE report 22731079 ↗
• InjuryMay 6, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Dyspnea

  MAUDE report 21970598 ↗
• InjuryApr 17, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF SIX (6) YEARS, THREE (3) MONTHS DUE TO AORTIC STENOSIS. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND SYNCOPE. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT IS A 46-YEAR-OLD MALE WITH HISTORY OF LIVER CIRRHOSIS (CHILD-PUGH CLASS B).

  Patient problems: Heart Failure/Congestive Heart Failure; Presyncope

  MAUDE report 21857531 ↗
• InjuryJan 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 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 21193040 ↗
• InjuryNov 7, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 21MM 2700TFX AORTIC VALVE IN THE AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 10 MONTHS DUE TO SEVERE STENOSIS. TAVR WAS COMPLETED WITH A 20MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20635100 ↗
• InjuryJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, NINE MONTHS DUE TO UNKNOWN REASONS. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX 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 19445115 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 3 MONTHS DUE TO ENDOCARDITIS (ENTEROBACTER FAECALIS). THE EXPLANTED DEVICE WAS REPLACED WITH A 19MM 3300TFX AORTIC VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS BROUGHT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. PER MEDICAL RECORDS, THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AFTER BEEN DIAGNOSED WITH ENTEROBACTER FAECALIS ENDOCARDITIS. THE PATIENT UNDERWENT REDO AVR UTILIZING 19MM 3300TFX AORTIC VALVE, RECONSTRUCTION OF AORTIC ROOT, PARTIAL REPLACEMENT OF ASCENDING AORTA WITH DACRON GRAFT, AND THROMBECTOMY OF ANTERIOR LEAFLET OF THE NATIVE MITRAL VALVE SECONDARY TO CONTIGUOUS SEPTIC THROMBUS ALONG WITH DEBRIDEMENT OF THE AORTIC ANNULUS. THE PATIENT TOLERATED THE PROCEDURE WELL, WAS BROUGHT TO THE RECOVERY ROOM IN SATISFACTORY CONDITION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON POD# 15.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 17607230 ↗
• InjuryJul 11, 2023Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A 21MM 2700TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 4 YEARS DUE TO AORTIC STENOSIS. THE PATIENT PRESENTED WITH WORSENING DOE AND PROGRESSION OF HFPEF. A 23MM NON-EDWARDS EVOLUT PRO VALVE WAS IMPLANTED. THE PATIENT WAS TAKEN TO PACU IN SATISFACTORY CONDITION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 17302786 ↗
• InjuryMay 22, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 7 MONTHS DUE TO HEMOPHILUS PARAINFLUENZA ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. PER MEDICAL RECORDS THE PATIENT PRESENTED WITH FEVER AND CHILLS, AFIB WITH RVR, TREATED WITH AMIODARONE. THE PATIENT WAS DIAGNOSED WITH HFLU BACTEREMIA, ACUTE BACTERIAL ENDOCARDITIS, BLOOD CULTURES WERE POSITIVE FOR HEMOPHILUS PARAINFLUENZA. THE PATIENT WAS TREATED WITH CONTINUOUS ANTIBIOTICS AND TRANSFERRED FOR SURGICAL WORKUP. PRIOR TO SURGERY THE PATIENT UNDERWENT TOOTH EXTRACTION. THE PATIENT WENT FOR HEART SURGERY ONE MONTH LATER AFTER TRANSFER. A PREOP TEE SHOWED THICKENING OF AV LEAFLETS, SEVERE 4+ MR WITH POSSIBLE VEGETATION, AND POSTERIOR LEAFLET PERFORATION, AND CENTRAL TR SECONDARY TO DILATION. INDICATION FOR SURGERY WAS INFECTION, ENDOCARDITIS AND PROSTHETIC VALVE DYSFUNCTION, MR AND TR. THE PATIENT UNDERWENT REDO AVR, CHORDAL SPARING MVR WITH A 27 MM NON-EDWARDS VALVE AND TVR WITH A STITCH. PATHOLOGY REPORT FOR EXPLANTED AORTIC VALVE INDICATED PANNUS FORMATION, THE LEAFLETS MOBILE. ON POD #11 A PPM WAS IMPLANTED

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 16972069 ↗
• InjuryDec 16, 2022Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 21MM AORTIC VALVE IS BEING EVALUATED FOR A TRANSCATHETER VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF 6 YEARS, AND 2 MONTHS DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 15997204 ↗