CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200 (REF 5200M26)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103180183), received between Jul 9, 2021 and Oct 7, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• MalfunctionOct 7, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A DURING A MITRAL ANNULOPLASTY REPAIR PROCEDURE THE PATIENT WAS SIZED FOR A 28MM RING. WHEN THE CIRCULATOR HANDED THE SCRUB NURSE THE RING IT WAS NOTED THAT THE BLUE TAG SAID IT WAS A 26MM RING. IT WAS NOTED BY THE SURGICAL TEAM THAT THE BOX SAID 28MM; HOWEVER, THE RING WAS ACTUALLY A 26MM 5200M. ANOTHER 28MM 5200M RING WAS GRABBED AND IMPLANTED. THE PATIENT WAS NOTED TO BE DOING GREAT POST PROCEDURE. IT WAS NOTED THAT THE SIZING DISCREPANCY WAS NOTICED PRIOR TO THE PROCEDURE. THE 26MM 5200M RING AND ITS BOX WERE DISCARDED. THERE ARE NO PHOTOS OF THE SUBJECT DEVICE NOR ITS PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563246 ↗
• InjuryJul 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  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. EDWARDS IMPLANT PATIENT REGISTRY RECEIVED INFORMATION A 36MM MITRAL RING WAS EXPLANTED AFTER TWO (2) YEARS, DUE DEHISCENCE OF SUTURE AROUND 12 AND 4 O'CLOCK WHICH LED TO SEVERE MITRAL REGURGITATION AND MITRAL VALVE PROLAPSE. PATIENT PRESENTED WITH RECURRENT DYSPNEA ON EXERTION AND WAS FOUND TO HAVE SEVERE MITRAL REGURGITATION ON ECHO. THE EXPLANTED RING WAS REPLACED WITH A 36MM RING AND PLACEMENT OF GORETEX NEOCHORDS. THE PATIENT WAS TRANSFERRED TO THE ICU IN STABLE BUT CRITICAL CONDITION.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 12143829 ↗