Physio Flex Annuloplasty Ring 5300Recalls & reported problems
Edwards Lifesciences LLC · Physio Flex Annuloplasty Ring · Class 2 · Implant
Data updated Oct 16, 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 00690103206197), received between Jun 10, 2022 and Nov 8, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Protrusion/Extrusion1
Patient problems
- Mitral Valve Insufficiency/ Regurgitation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
CUSTOMER REPORT OF NITINOL CORE EXPOSED ON RING WAS UNABLE TO BE CONFIRMED THROUGH PROVIDED IMAGE. ONE PHOTO OF A IMPLANTED RING WAS PROVIDED. MULTIPLE FASTENERS WERE VISIBLE ON THE RING. CUSTOMER REPORT OF EXPOSED RING NITINOL CORE WAS CONFIRMED THROUGH VIDEO EVALUATION. IT APPEARED IN THE VIDEO THAT THE NITINOL CORE WIRE WAS EXPOSED AT THE END OF THE RING WHILE SUTURE FASTENERS WERE BEING ATTACHED TO THE RING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20640830 ↗InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EDWARDS LEARNED THAT THIS 30MM 5300M RING WAS EXPLANTED AT IMPLANT DUE TO MITRAL REGURGITATION. AFTER DECANNULATION BEFORE CLOSING THE PATIENT'S CHEST, REGURGITATION WAS STILL DETECTED. THE DEVICE WAS EXPLANTED AND REPLACED WITH A 27MM 11400M VALVE WITH NO ADVERSE PATIENT EVENTS REPORTED. THE PATIENT STATUS WAS REPORTED AS "UNDER TREATMENT". THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED AT THE HOSPITAL. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THIS DEVICE WAS ORIGINALLY IMPLANTED FOR MITRAL VALVULOPLASTY TO CORRECT MITRAL REGURGITATION WITH A CONCOMITANT AORTIC VALVE REPLACEMENT WITH A 21 MM 11500AJ VALVE.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 14659270 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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