CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC 2800 (REF 280027MM)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103021684), received between Sep 1, 2021 and Jun 10, 2025 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 27MM 2800 AORTIC VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN APPROXIMATE IMPLANT DURATION OF 8 YEARS, 7 MONTHS DUE TO SEVERE PULMONIC REGURGITATION AND MODERATE STENOSIS. THE PATIENT PRESENTED WITH CHEST PAIN AND DIZZINESS. THE TPVR WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS TRANSFERRED TO THE PACU IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Chest Pain; Dizziness

  MAUDE report 22177572 ↗
• InjuryJun 5, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2800 AORTIC VALVE, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS DUE TO STENOSIS. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 26MM 9755RSL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 22151987 ↗
• InjuryAug 21, 2023Gradient Increase; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2800 AORTIC VALVE IS UNDER EVALUATION FOR VALVE-IN-VALVE AFTER AN IMPLANT DURATION OF 7 YEARS, 10 MONTHS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SOB. THE TAVR IS SCHEDULED FOR (B)(6) 2023.

  Patient problems: Dyspnea

  MAUDE report 17592053 ↗
• InjurySep 1, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS LEARNED THAT THE PATIENT HAD A 27MM 2800 PERICARDIAL VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT AN ATTEMPT FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 16 YEARS, ONE (1) MONTH DUE TO STENOSIS AND INSUFFICIENCY. THE PATIENT UNDERWENT BALLOON VALVULOPLASTY OF THE BIOPROSTHETIC VALVE WITH INTENTIONAL FRACTURE OF THE VALVE RING TO DELIVER A SAPIEN VALVE. THE PROCEDURE WAS NOT SUCCESSFUL DUE TO THE PROLONG PROCEDURE TIME AND THE FLUOROSCOPY TIME. THE PROCEDURE HAD TO BE STAGED.

  Patient problems: Insufficient Information; Pleural Effusion

  MAUDE report 12411692 ↗