CARPENTIER-EDWARDS Perimount Pericardial Aortic ProsthesisRecalls & reported problems across all models
Edwards Lifesciences LLC · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 135
- Deaths reported
- 0
- Injuries reported
- 135
- Recalls
- 0
We found 6 models of CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 135 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2021 and Sep 18, 2026 — classified as 135 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (70 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 Pericardial Aortic Prosthesis problems
Device problems
- Insufficient Device Problem Information70
- Device Stenosis32
- Gradient Increase23
- Calcified17
- Degraded13
- Fluid/Blood Leak13
- Patient Device Interaction Problem12
- Adverse Event Without Identified Device or Use Problem11
Patient problems
- Insufficient Information95
- Heart Failure/Congestive Heart Failure39
- Dyspnea30
- Endocarditis13
- Fatigue6
- Swelling/ Edema4
- Chest Pain3
- No Clinical Signs, Symptoms or Conditions2
CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve55 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve29 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve25 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve14 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve9 reports
- CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis 2700TFXReplacement Heart-Valve3 reports
Recent CARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 18, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50831464 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
It was learned through Implant Patient Registry that a patient with a 23mm 2700TFX aortic valve was explanted after an implant duration of 5 years, 1 months due to unknown reasons. The explanted valve was replaced with a 23mm 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: Endocarditis; Insufficient Information
MAUDE report 50261880 ↗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 ↗InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A VALVED CONDUIT. 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; Insufficient Information
MAUDE report 24651333 ↗InjuryFeb 20, 2026Insufficient Device Problem Information
IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 19MM 2700TFX PERICARDIAL AORTIC VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, THREE (3) 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: Insufficient Information
MAUDE report 24405253 ↗InjuryFeb 10, 2026Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 8 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 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 24309631 ↗InjuryJan 26, 2026Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. 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 24182819 ↗InjuryJan 5, 2026Device Stenosis
IT WAS REPORTED THAT A 23MM 2700TFX AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED IN HEART FAILURE REQUIRING HOSPITALIZATION AND TREATMENT. TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. PER MEDICAL RECORDS, PATIENT WAS ADMITTED FOR VALVE-RELATED HEART FAILURE REQUIRING ICU ADMISSION AND FURTHER MANAGEMENT. PATIENT REFUSED SAVR AND UNDERWENT TAVR PROCEDURE WITH LOW CARDIAC OUTPUT REQUIRING SHORT EPISODE OF CHEST COMPRESSIONS AND DISCHARGED ON POD3. PATIENT UNDERWENT TF-VIV TAVR WITH # 23 S3 POST-DILATED WITH 22 MM TRUE BALLOON.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 23970215 ↗InjuryJan 2, 2026Calcified; Insufficient Device Problem Information
IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 3 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 2MM 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 23952314 ↗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 ↗InjuryDec 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 11 MONTHS TO REPAIR AORTIC DISSECTION. THE PATIENT PRESENTED WITH CHEST PAIN. THE EXPLANTED DEVICE WAS REPLACED WITH A 25MM 11060A AORTIC VALVED CONDUIT. THE PATIENT WAS DISCHARGED ON POD #8.
Patient problems: Insufficient Information
MAUDE report 23851362 ↗InjuryDec 2, 2025Calcified; Calcified
IT WAS REPORTED THAT A PATIENT WITH A 25MM 2700TFX AORTIC VALVE UNDERWENT EMERGENCY VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO SEVERE CALCIFICATION AND DEGENERATION. THE PATIENT PRESENTED WITH ACUTE HEART FAILURE. TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST-PROCEDURE AND DISCHARGED ON POD #3. PER MEDICAL RECORDS, PATIENT PRESENTED IN THE ER WITH CHEST PAIN/NSTEMI UNDERWENT LHC. TEE SHOWED SEVERE CALCIFICATION AND DEGENERATION OF THE BIOPROSTHETIC AORTIC VALVE WITH SEVERE STENOSIS, MG 50MMHG AND SEVERE TRANSVALVULAR REGURGITATION. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND UNDERWENT EMERGENT VIV.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 23701021 ↗InjuryOct 29, 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 25MM 2700TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYNCOPE. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION POST PROCEDURE AND DISCHARGED ON POD #8.
Patient problems: Insufficient Information; Syncope/Fainting
MAUDE report 23416023 ↗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 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page