CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800 (REF 280023MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00690103021660), received between May 28, 2021 and Sep 5, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 11 most recent of 11 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 2800 IMPLANTED NINE (9) YEARS, SIX (6) 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 problems: Dyspnea

  MAUDE report 22982812 ↗
• InjuryJul 17, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800 AORTIC VALVE IS UNDER CONSIDERATION A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO UNKNOWN REASONS.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22531000 ↗
• InjuryMay 30, 2025Calcified; Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 2800 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 9 YEARS, 5 MONTHS DUE TO CALCIFICATION AND STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS RELISA AORTIC VALVE. PATIENT WAS STABLE AND WAS SENT TO RECOVERY POST PROCEDURE. THIS IS A 72-YEAR MALE PATIENT. 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 22112412 ↗
• InjuryMay 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 2800 AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS, 5 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: Insufficient Information

  MAUDE report 22101650 ↗
• InjuryMar 21, 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 23MM 2800 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 1 MONTH DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS IN ICU POST PROCEDURE, WAS DISCHARGE ON POD#22.

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

  MAUDE report 21669997 ↗
• InjuryNov 16, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 5 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 20MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 20701822 ↗
• InjuryJun 11, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 2800 AORTIC VALVE IN PULMONARY POSITION WAS DISABLED VIA VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, 4 MONTHS DUE TO REGURGITATION WITH PROGRESSIVE INCREASE IN GRADIENTS (PEAK 40-50MMHG). THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. TPVR WAS COMPLETED WITH A 23MM 9600TFX TRANSCATHETER VALVE AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 19508757 ↗
• InjuryMar 22, 2024Device Stenosis; Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A 23MM 2800 AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, THREE (3) MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, SHORTNESS OF BREATH, AND CHEST PAIN. TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS STABLE AT THE END OF THE PROCEDURE.

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

  MAUDE report 18958629 ↗
• InjuryJun 5, 2022Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800 PERICARDIAL AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, FOUR (4) MONTHS DUE TO AORTIC STENOSIS. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. THE PATIENT WAS NOTED TO BE STABLE POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 14599642 ↗
• InjuryOct 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THROUGH EDWARDS IMPLANT PATIENT REGISTRY, IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 14 YEARS, ONE (1) MONTH DUE TO UNKNOWN REASONS. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE. AS REPORTED, THERE IS NO INDICATION THAT THE DEVICE FAILED PREMATURELY.

  Patient problems: Insufficient Information

  MAUDE report 12637304 ↗
• InjuryMay 28, 2021Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 2800 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 18 YEARS, ONE (1) MONTH DUE TO SEVERE SYMPTOMATIC STENOSIS. THE PATIENT PRESENTED WITH CHRONIC DIASTOLIC HEART FAILURE CLASS 2-3. THE SURGICAL VALVE WAS FRACTURED WITH A TRUE BALLOON, AND THE TAVR WAS PERFORMED SUCCESSFULLY WITH A 23MM S3 ULTRA TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED TO HOME ON POD #1 IN A STABLE CONDITION. THERE WAS NO ALLEGATION THAT THE SURGICAL VALVE FAILED OR MALFUNCTIONED PREMATURELY.

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

  MAUDE report 11901393 ↗