CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING 6200TRecalls & 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 00690103188455), received between Sep 21, 2021 and Sep 21, 2021 — classified as 1 injury.
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
Device problems
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- Heart Failure/Congestive Heart Failure1
- Tricuspid Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2021Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT WITH A 30MM 6200 ANNULOPLASTY RING, IMPLANTED IN THE TRICUSPID POSITION, WAS ABOUT TO UNDERGO A VALVE-IN-RING PROCEDURE AFTER AN IMPLANT DURATION OF FIVE (5) YEARS, 10 MONTHS DUE TO SEVERE TRICUSPID REGURGITATION. THE PATIENT PRESENTED WITH RIGHT SIDED HEART FAILURE NYHA CLASS III-IV. THE PROCEDURE WAS TO BE PERFORMED WITH A 29MM 9600TFX TRANSCATHETER VALVE. THE PROCEDURE WAS ABANDONED BASED ON FLUOROSCOPY FINDINGS BEFORE THE VALVE WAS EVER INTRODUCED INTO THE BODY. THE VALVE WAS NEVER PREPPED OR INTRODUCED INTO THE BODY. AS REPORTED, THE RING SHOWS IMPORTANT DEHISCENCE AT THE SUPERIOR END OF THE OPEN RING AT THE AOV LEVEL THAT MAY OR NOT BE INCREASED AFTER THE IMPLANT WITH INSTABILITY OF THE RING AND THE VALVE. THERE IS A LARGE SEPTAL POUCH (BIGGER THAN THE RING) THAT CAN BE RESPONSIBLE OF SEVERE TRICUSPID REGURGITATION IF NOT TREATED WITH CORRECT CLOSURE DEVICE (AVP II 22 AT LEAST 2 MAY BE 3 DEVICES OR ASO WITH RISK OF INTERFERENCE WITH S3 VALVE FUNCTION). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Heart Failure/Congestive Heart Failure; Tricuspid Valve Insufficiency/ Regurgitation
MAUDE report 12509474 ↗
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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