CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800 (REF 280021MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103021653), received between Apr 20, 2021 and Mar 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Gradient Increase” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2800 AORTIC VALVE IN AORTIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 9 YEARS, 1 MONTH DUE TO STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL VALVE. PATIENT LEFT PROCEDURE AREA STABLE.

  Patient problems: Dyspnea

  MAUDE report 21633211 ↗
• InjuryApr 13, 2022Calcified; Gradient Increase; Calcified; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2800 AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 5 MONTHS DUE TO SEVERE AORTIC STENOSIS SECONDARY TO CALCIFICATION IN THE NONCORONARY CUSP AND RIGHT CORONARY CUSP. THE TAVR WAS PERFORMED WITH A 23MM 9750TFX TRANSCATHETER VALVE AND THE PROCEDURE WENT WELL.

  Patient problems: Insufficient Information

  MAUDE report 14105087 ↗
• InjuryApr 20, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 2800 PERICARDIAL VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 17 YEARS, SEVEN (7) MONTHS DUE TO STENOSIS AND REGURGITATION. THE TAVR WAS PERFORMED WITH A 20MM 9750TFX TRANSCATHETER VALVE. THERE WAS NO ALLEGATION THAT THE SURGICAL VALVE FAILED OR MALFUNCTIONED PREMATURELY.

  Patient problems: Insufficient Information

  MAUDE report 11697797 ↗