CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS – AORTIC 2800TFX (REF 2800TFX19MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103194074), received between Apr 24, 2025 and Jul 8, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 19MM 2800TFX AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS, 10 MONTHS DUE TO PPM. THE PATIENT PRESENTED WITH SOB. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A VALVE. THE PATIENT WAS TRANSFERRED TO THE CVICU IN STABLE CONDITION POST PROCEDURE. THE PATIENT WAS DISCHARGED POD 12. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SOB AND EXERCISE INTOLERANCE. PRE-OP TEE REVEALED PATIENT PROSTHESIS MISMATCH OF AORTIC VALVE. REDO STERNOTOMY WAS PERFORMED TO REPLACE THE 19MM 2800TFX WITH A 23MM 11500A VALVE. AORTIC ROOT ENLARGEMENT WAS PERFORMED CONCOMITANTLY. A 25MM INSPIRIS WAS INITIALLY PLACED BUT DID NOT SEAT WELL, SO IT WAS REMOVED AND REPLACED WITH A 23MM INSPIRIS (B)(4) THE PATIENT WAS TRANSFERRED TO THE CVICU IN STABLE CONDITION POST PROCEDURE. THE PATIENT WAS DISCHARGED POD #12. 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 NOTIFI

  Patient problems: Dyspnea

  MAUDE report 22443121 ↗
• InjuryApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WITH A 19MM 2800TFX AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 3 MONTHS DUE TO AORTIC INSUFFICIENCY. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE, CHEST PAIN, AND SHORTNESS OF BREATH. THE PROCEDURE WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 21905698 ↗