CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING 5200 (REF 5200M32)Recalls & reported problems
Edwards Lifesciences LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103180213), received between Jun 23, 2025 and Jun 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Pseudoaneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS LEARNED FROM THE MEDICAL RECORD OF (B)(6) THAT THE 5200 CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF TWO (2) YEARS AND FIVE (5) MONTHS DUE TO RING DEHISCENCE WITH LARGE PSEUDOANEURYSM AND SEVERE MITRAL STENOSIS. THE EXPLANT RING WAS REPLACED WITH A 29MM NON-EDWARDS VALVE. PER MEDICAL RECORDS, THE PATIENT WAS ASYMPTOMATIC. INTRAOPERATIVELY, THERE WAS GIANT ANEURYSM IN AORTIC ROOT WITH FISTULA FORMATION TO LA OVER MITRAL ANNULOPLASTY RING. THE OLD PROSTHETIC 23MM INSPIRIS VALVE WAS EXPLANTED (B)(6). THE 32MM 5200 ANNULOPLASTY RING WAS ALSO LOOSELY CONNECTED TO ANNULUS AND WAS EXPLANTED. THE GIANT PSEUDOANEURYSM DESTROYED ANTERIOR MITRAL LEAFLET, AORTORNITRAL CURTAIN, AND PERINUCLEAR TISSUE. THE MITRAL VALVE WAS REPLACED WITH A 29MM NON-EDWARDS VALVE WITH RECONSTRUCTION OF AORTOMITRAL CURTAIN WITH BOVINE PERICARDIAL PATCH (COMMANDO PROCEDURE), AORTIC ROOT REPLACEMENT WITH 23MM KONNECT AVC AND RVOT REPAIR ANOTHER BOVINE PERICARDIAL PATCH. 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
Patient problems: Pseudoaneurysm
MAUDE report 22311857 ↗
Other RING, ANNULOPLASTY devices
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- PROFILE 3D® 680R28Medtronic, Inc. · RING, ANNULOPLASTY1 death67 reports
- CG FUTURE™ 638BL30Medtronic, Inc. · RING, ANNULOPLASTY1 death65 reports
- CG FUTURE™ 638RL32Medtronic, Inc. · RING, ANNULOPLASTY59 reports
- Tri-Ad™ 900SFC228Medtronic, Inc. · RING, ANNULOPLASTY4 deaths56 reports
- CG FUTURE™ 638BL34Medtronic, Inc. · RING, ANNULOPLASTY51 reports
- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638BL28Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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