CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTICRecalls & reported problems across all models
Edwards Lifesciences LLC · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls
- 0
We found 2 models of CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 34 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2021 and Sep 2, 2025 — classified as 34 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC problems
Device problems
- Insufficient Device Problem Information16
- Device Stenosis10
- Gradient Increase8
- Calcified4
- Adverse Event Without Identified Device or Use Problem2
- Degraded2
- Fluid/Blood Leak2
- Intravalvular regurgitation2
Patient problems
- Insufficient Information25
- Heart Failure/Congestive Heart Failure12
- Dyspnea11
- Cardiogenic Shock2
- Atrial Fibrillation1
- Chest Pain1
- Endocarditis1
- Fatigue1
CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC 3000replacement Heart-valve19 reports
- CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC 3000replacement Heart-valve15 reports
Recent CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS AORTIC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 22948651 ↗InjuryAug 8, 2025Device Stenosis; Device Stenosis
IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 PERICARDIAL AORTIC VALVE UNDERWENT VALVE-IN-VALVE INTERVENTION AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS DUE TO SEVERE AORTIC STENOSIS WITH AN ELEVATED GRADIENT OF 30+MMHG. THE PATIENT INITIALLY PRESENTED WITH SHORTNESS OF BREATH. THE TAVR PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE WITH NO RESULTING CENTRAL LEAK.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 22746614 ↗InjuryAug 4, 2025Calcified; Device Stenosis; Calcified; Device Stenosis
IT WAS REPORTED THROUGH SMART START THAT A PATIENT WITH A 27MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS DUE TO CALCIFICATION. THE PROCEDURE WAS PERFORMED WITH A 26MM 9755RSL TRANSCATHETER VALVE.
Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information
MAUDE report 22699307 ↗InjuryMay 29, 2025Device Stenosis; Device Stenosis
IT WAS REPORTED THAT A PATIENT WITH A 27MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 8 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9750TFX VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #5.
Patient problems: Dyspnea
MAUDE report 22111485 ↗InjuryApr 2, 2025Calcified; Calcified
IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS, THAT A 27MM 3000 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF NINE (9) YEARS, FOUR (4) MONTHS DUE TO CALCIFIC DEGENERATION AND SEVERE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A NON-EDWARDS MECHANICAL VALVE. PATIENT WAS TAKEN TO RECOVERY POST PROCEDURE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH DYSPNEA ON EXERTION AND INCREASE FATIGUE. PRE- OP IMAGING DEMONSTRATE ENLARGING SINUS OF VALSALVA ANEURYSM WITH STRUCTURAL VALVE DETERIORATION OF THE BIOPROSTHETIC AORTIC VALVE WITH SEVERE AS AND REDUCED EF AT 52%. THE PATIENT UNDERWENT A REDO STERNOTOMY IN WHICH THE 27MM 3000 MAGNA EASE WAS EXPLANTED AND REPLACED WITH NON-EDWARDS MECHANICAL VALVE. CONCOMITANTLY, THE PATENT UNDERWENT TRICUSPID VALVE REPAIR USING 32MM 6200 PHYSIO RING. UPON WEANING FROM BYPASS, THE PATIENT WAS PROFOUNDLY VASOPLEGIC WITH MINIMAL RESPONSE TO VASOCONSTRICTORS. VA ECMO CIRCUIT WAS PLACED WITHOUT ISSUE AND THE PATIENT WAS TRANSFERRED TO CVICU IN STABLE CONDITION. THE PATIENT WAS DISCHARGED FROM HOSPITAL POD # 13. PER PATHOLOGY REPORT, FRAGMENTS OF FIBROCONNECTIVE TISSUE WITH DYSTROPHIC CALCIFICATIONS, NECROSIS, ACUTE IN
Patient problems: Dyspnea; Fatigue
MAUDE report 21756636 ↗InjuryJan 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 3000 AORTIC VALVE, WAS EXPLANTED AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, EIGHT (8) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 3300TFX 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 21096633 ↗InjuryNov 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A MODEL 3000 27MM PERICARDIAL VALVE IN PULMONARY POSITION WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. A 9600TFX 29MM TRANSCATHETER VALVE WAS IMPLANTED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 20735865 ↗InjuryNov 11, 2024Calcified; Device Stenosis; Calcified; Device Stenosis
IT WAS REPORTED AND INVESTIGATION THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO CALCIFICATION, DEGENERATION, AND STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SOB. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.
Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Insufficient Information
MAUDE report 20655580 ↗InjuryNov 5, 2024Device Stenosis; Device Stenosis
IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, SIX (6) MONTHS DUE TO CRITICAL AORTIC STENOSIS. THE PATIENT PRESENTED WITH SYSTOLIC HEART FAILURE. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 20612525 ↗InjuryOct 10, 2024Device Stenosis; Device Stenosis
IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SIX (6) YEARS AND TEN (10) MONTHS DUE TO STENOTIC LEAFLETS. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PROCEDURE WAS A PLANNED OPEN-HEART PROCEDURE, AND IT WAS SUCCESSFUL.
Patient problems: Insufficient Information
MAUDE report 20423987 ↗InjuryOct 8, 2024Device Stenosis; Device Stenosis
IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE IS UNDER CONSIDERATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 10 MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE PROCEDURE HAS NOT BEEN SCHEDULED YET. THIS IS A 82-YEAR-OLD FEMALE PATIENT.
Patient problems: Dyspnea
MAUDE report 20403251 ↗InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 21MM 3000 AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASON. THE PROCEDURE WAS PERFORMED WITH A 20MM 9755RSL VALVE. THE PATIENT WAS TAKEN TO RECOVERY 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: Insufficient Information
MAUDE report 19538773 ↗InjuryJun 4, 2024Calcified; Calcified
IT WAS REPORTED THAT A PATIENT WITH A 21MM 3000 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS DUE TO STENOSIS SECONDARY TO CALCIFICATION. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE WITH GREAT RESULT.
Patient problems: Insufficient Information
MAUDE report 19461728 ↗InjuryJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THROUGH IMPLANT PATIENT REGISTRY IT WAS LEARNED THAT A 21MM 3000 VALVE IN THE AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO UNKNOWN REASON. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE.
Patient problems: Insufficient Information
MAUDE report 19454548 ↗InjuryApr 17, 2024Device Stenosis; Device Stenosis
IT WAS REPORTED THAT A 27MM 3000 AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 1 MONTH DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE, AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.
Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure
MAUDE report 19128717 ↗
Other Edwards Lifesciences LLC products
- Edwards SAPIEN 315 models · 6,905 reports · 1 recall
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
- INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
- EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
- SAPIEN 3 Ultra RESILIA4 models · 881 reports
- SAPIEN 3 Ultra System3 models · 876 reports
- FOGARTY32 models · 486 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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