CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC 2625Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103021554), received between Mar 19, 2021 and Nov 7, 2021 — classified as 2 injuries.

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

• InjuryNov 7, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2625 VALVE, IMPLANTED IN THE AORTIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, 11 MONTHS DUE TO STENOSIS AND REGURGITATION. THE TAVR WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE WITH GREAT OUTCOME. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

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

  MAUDE report 12759151 ↗
• InjuryMar 19, 2021Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase

  IT WAS REPORTED THAT A PATIENT WITH A 27MM 2625 AORTIC PORCINE VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 22 YEARS, EIGHT (8) MONTHS DUE TO PULMONARY STENOSIS AND REGURGITATION. THE TPVR WAS PERFORMED WITH A 26MM 9600TFX TRANSCATHETER VALVE. THERE WERE NO COMPLICATIONS AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS DISCHARGED HOME ON POD #1 IN GOOD CONDITION.

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

  MAUDE report 11529515 ↗