CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH HOLDER - MITRAL 4450 (REF 4450M36)Recalls & reported problems
Edwards Lifesciences LLC · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103020274), received between May 2, 2023 and Mar 20, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Gradient Increase1
- Intravalvular regurgitation1
Patient problems
- Insufficient Information1
- Mitral Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 20, 2025Intravalvular regurgitation; Intravalvular regurgitation
IT WAS REPORTED AND LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 36MM 4450 MITRAL RING WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS AND TWO MONTHS DUE TO REGURGITATION AND DEHISCENCE. THE EXPLANTED RING WAS REPLACED WITH 31MM 11400M MITRIS RESILIA MITRAL VALVE. THE PATIENT WAS TRANSFERRED TO THE ICU BEFORE BEING DISCHARGED IN STABLE CONDITION. PER PA, THE PERCEIVED ROOT CAUSE OF THE EVENT WAS DUE TO STRUCTURAL DEFICIENCY OF THE ANNULOPLASTY RING.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 21649855 ↗InjuryMay 2, 2023Fluid/Blood Leak; Gradient Increase; Fluid/Blood Leak; Gradient Increase
IT WAS REPORTED THAT AN UNKNOWN MODEL VALVE IN THE MITRAL POSITION WAS DISABLED VIA A VALVE-IN-VALVE PROCEDURE AFTER AN UNKNOWN IMPLANT DURATION DUE TO MITRAL STENOSIS AND REGURGITATION. A 9755RSL 29MM TRANSCATHETER VALVE WAS SUCCESSFULLY IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 16853251 ↗
Other RING, ANNULOPLASTY devices
- CG FUTURE™ 638BL32Medtronic, Inc. · RING, ANNULOPLASTY1 death71 reports
- 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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