CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200 (REF 5200M30)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00690103180206), received between Apr 21, 2022 and Apr 14, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT A PATIENT WITH A FAILING 30MM 5200 ANNULOPLASTY RING, IMPLANTED IN THE MITRAL POSITION, UNDERWENT A VALVE-IN-RING PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 5 MONTHS DUE TO STENOSIS. THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 16747085 ↗
• MalfunctionFeb 21, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT A 30MM 5200M RING THE INNER PACKAGE (TYVEK) WAS OBSERVED TO BE PARTIALLY OPENED UPON OPENING THE OUTER PACKAGE IN THE OPERATING ROOM. THE DEVICE WAS NOT USED AND WILL BE RETURNED. A PHOTO WAS PROVIDED. PER ADDITIONAL INFORMATION, THE OUTER BOX WAS SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414382 ↗
• MalfunctionFeb 13, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Delivered as Unsterile Product; Unsealed Device Packaging

  IT WAS REPORTED THAT A 30MM 5200M MITRAL RING PACKAGE WAS REMOVED FROM SEALED BOX WITHIN THE OPERATING ROOM. THE OUTER PACKAGE WAS OPENED IN THE USUAL FASHION, HOWEVER, ON INSPECTION, THE INNER PACKAGE WAS FOUND PEELED BACK SLIGHTLY. THE RING WAS NOT PLACED ON THE FIELD AS UNABLE TO VERIFY THE STERILITY OF THE INNER PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364903 ↗
• InjuryAug 29, 2022Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem; Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH A 30MM 5200M ANNULOPLASTY RING IN THE MITRAL POSITION UNDERWENT A VALVE-IN-RING PROCEDURE AFTER AN IMPLANT DURATION OF SEVEN (7) MONTHS DUE TO MITRAL REGURGITATION. THE MVIR PROCEDURE WAS PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WITHOUT DIFFICULTIES AND WAS SENT TO RECOVERY WITH STABLE VITALS. THE PHYSICIAN FELT THE ANNULOPLASTY RING DID FAIL BECAUSE IT WAS IMPLANTED FOR LESS THAN ONE YEAR.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15316464 ↗
• InjuryApr 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 5200 30MM MITRAL RING WAS EXPLANTED AT IMPLANT DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH A 7300TFX 31MM BIOPROSTHETIC VALVE. THE IMPLANTATION DATA CARD INDICATED THAT THE DEVICE EXPLANT WAS DUE TO DEFICIENCY OF THE ORIGINAL DEVICE. 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 14168652 ↗