CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS 7300TFX (REF 7300TFX25)Recalls & reported problems

Summary

The FDA's MAUDE database contains 290 adverse event reports that list this exact device (DI 00690103186253), received between Feb 19, 2021 and Mar 19, 2026 — classified as 1 death, 289 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (106 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 25 most recent of 290 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 1 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 24643003 ↗
• InjuryMar 13, 2026Degraded

  PER THE REPORT RECEIVED FROM CANADA, A 70-YEAR-OLD PATIENT WITH A VALVE MODEL 7300TFX25 IMPLANTED IN MITRAL POSITION UNDERWENT REINTERVENTION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS AND ONE (1) MONTH DUE TO DEGENERATION LEADING TO SEVERE STENOSIS (MEAN GRADIENT OF 20MMHG). AS REPORTED, THE PATIENT PRESENTED WITH DYSPNEA, CHEST PAIN, AND HEART FAILURE SECONDARY TO VALVULAR DISEASE. APPROXIMATELY TWO (2) YEARS AND SIX (6) MONTHS AFTER THE INITIAL IMPLANT, THE PATIENT WAS HOSPITALIZED WITH DYSPNEA AND SUSPECTED EARLY VALVE DEGENERATION; HOWEVER, THE CONDITION IMPROVED WITHOUT VALVE INTERVENTION. A 26 MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24597591 ↗
• InjuryFeb 9, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 25MM 7300TFX MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS, 7 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11400M MITRAL 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 24292777 ↗
• InjuryJan 30, 2026Insufficient Device Problem Information

  EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY (IPR). 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. IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY (IPR) THAT A 45-YEAR-OLD PATIENT WITH THIS DEVICE MODEL 7300TFX25 IMPLANTED IN MITRAL POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS AND EIGHT (8) MONTHS DUE TO UNKNOWN REASONS. A 27MM SURGICAL VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 24219535 ↗
• InjuryDec 17, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, 11 MONTHS DUE TO MODERATE MITRAL REGURGITATION. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. THE PATIENT WAS ORIGINALLY SCHEDULED FOR INTERVENTION ON (B)(6) 2025 BUT WAS THEN CANCELLED DUE TO LEFT ATRIAL CLOT FOUND WHILE THE PATIENT WAS ON THE OR TABLE. THE TMVR PROCEDURE WAS SUCCESSFULLY PERFORMED AFTER AN IMPLANT DURATION OF 10 YEARS, ONE (1) MONTH RESULTING IN THE IMPLANT OF A 26MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 23831274 ↗
• InjuryOct 20, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE IS UNDER EVALUATION FOR A VALVE-IN-VALE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS AND SIX (6) MONTHS DUE TO STENOSIS.

  Patient problems: Insufficient Information

  MAUDE report 23343835 ↗
• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 3 MONTHS DUE TO UNKNOWN REASON. THE TMVR WAS PERFORMED WITH A 26MM 9755RSL 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 23317241 ↗
• InjuryOct 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE IN MITRAL POSITION UNDERWENT A VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 23313878 ↗
• InjuryOct 15, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE HAS BEEN PLACED UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED CHF NYHA III. PER MEDICAL RECORDS, PRE-OP TEE SHOWED MV WITH INCREASED VALVULAR GRADIENT WITH A MG 11MMHG, AND EF 65-70%.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23292688 ↗
• InjurySep 16, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE HAS BEEN SCHEDULED FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, SEVEN (7) MONTHS DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN/TIGHTNESS.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 23069076 ↗
• InjurySep 11, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 4 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE TMVR WAS PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS IN STABLE CONDITION POST 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: Heart Failure/Congestive Heart Failure

  MAUDE report 23031014 ↗
• InjurySep 10, 2025Calcified; Calcified

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 1 YEARS, 8 MONTHS DUE TO MODERATE CALCIFICATION, SEVERE STENOSIS, AND DEGENERATION. THE PATIENT PRESENTED WITH NYHA CLASS II CHRONIC DIASTOLIC HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST PROCEDURE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SOB. PRE-OP TTE ((B)(6) 2025) SHOWED AN EF OF 65%-70%, MODERATE CALCIFICATION OF THE MITRAL BIOPROSTHETIC VALVE. PRE-OP TEE ((B)(6) 2025) REVEALED MEAN GRADIENT OF 11MMHG WITH SEVERE STENOSIS. TMVR PROCEDURE WAS COMPLETED USING A 26MM RESILIA VALVE. A TEMPORARY PACEMAKER WAS PLACED AND REMOVED FOR THIS SURGERY. 26MM RESILIA WAS PLACED WITH NO COMPLICATION. INTRA-OP TEE CONFIRMED DECREASE IN GRADIENT AS WELL AS NO PVL. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23020954 ↗
• InjurySep 5, 2025Calcified; Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX PERICARDIAL MITRAL VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FOUR (4) MONTHS DUE TO CALCIFICATION. THE TMVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 22979829 ↗
• InjurySep 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE IS UNDER EVALUATION FOR A VALVE-IN-VALE PROCEDURE AFTER AN IMPLANT DURATION OF THREE (3) YEARS AND SIX (6) MONTHS DUE TO UNKNOWN REASON. THE PATIENT PRESENTED HEART FAILURE, COUGH, SHORTNESS OF BREATH, FATIGUE, AND LEG SWELLING.

  Patient problems: Cough; Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Swelling/ Edema

  MAUDE report 22947978 ↗
• InjurySep 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX PERICARDIAL MITRAL VALVE WAS PLACED UNDER EVALUATION FOR VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF NINE (9) YEARS, NINE (9) MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 22945776 ↗
• InjuryAug 29, 2025Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem

  AS PER THE REPORT RECEIVED FROM BRAZIL, THIS VALVE MODEL 7300TFX25MM WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS AND TEN (10) MONTHS FOR UNKNOWN REASON. A NON-EDWARDS MECHANICAL VALVE WAS IMPLANTED IN REPLACEMENT.

  Patient problems: Fatigue; Insufficient Information

  MAUDE report 22920765 ↗
• InjuryAug 28, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED A PATIENT WITH A 25MM 7300TFX MITRAL VALVE IMPLANTED FOUR (4) YEARS, ONE (1) MONTH, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO MITRAL STENOSIS. TMVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22918522 ↗
• InjuryAug 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 7300TFX 25MM MITRAL VALVE WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 11 MONTHS DUE TO UNKNOWN REASONS. A 9755RSL 26MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22913830 ↗
• InjuryAug 27, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE IS UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS AND 5 MONTHS DUE TO STENOSIS. THE PATIENT WAS PRESENTED WITH CHF, BILATERAL LOWER LEG EDEMA, AND LIGHTHEADEDNESS. THE PROCEDURE HAS NOT BEEN SCHEDULED YET.

  Patient problems: Dizziness; Heart Failure/Congestive Heart Failure; Insufficient Information; Swelling/ Edema

  MAUDE report 22905707 ↗
• InjuryAug 25, 2025Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH AN 25MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO UNKNOWN REASON. THE TMVR WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE.

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

  MAUDE report 22884714 ↗
• InjuryAug 21, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS DUE TO REGURGITATION. THE VALVE WAS REPLACED WITH A 26MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22865494 ↗
• InjuryAug 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS AND 6 MONTHS DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 22853466 ↗
• InjuryAug 20, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 4 MONTHS DUE TO SEVERE MITRAL STENOSIS AND MITRAL REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED ON POD #1.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22852311 ↗
• InjuryAug 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 2 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE. THE TMVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. PATIENT WAS TAKEN TO PACU POST PROCEDURE AND DISCHARGED THE NEXT DAY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 22841025 ↗
• InjuryAug 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 7300TFX MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 2 MONTHS DUE TO STENOSIS AND REGURGITATION. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND CHEST PAIN. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS TRANSFERRED TO ICU AND DISCHARGED ON POD#1. THIS IS A 76-YEAR-OLD FEMALE PATIENT.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22836412 ↗