CARBOMEDICS ANNULOFLO AR-732Recalls & reported problems
Corcym Srl · 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 08022057013699), received between Jun 14, 2017 and Jun 14, 2017 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2017, THE MANUFACTURER WAS NOTIFIED BY PATIENT REGISTRATION FORM (PRF) THAT AN ANNULOFLEX MITRAL ANNULOPLASTY RING SZ 32 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2017. DURING THE PROCEDURE THE PHYSICIAN IMPLANTED THE RING, TESTED THE NATIVE MITRAL VALVE AND THEN DECIDED TO REMOVE THE RING. THE PHYSICIAN PERFORMED A SURGICAL REPAIR AND NO RING OR HEART VALVE PROSTHESIS WAS IMPLANTED. THE PROCEDURE WAS EXTENDED BUT THE INCREASE IN X-CLAMP TIME WAS NOT REPORTED TO THE MANUFACTURER. THE RING WAS DISPOSED BY THE HOSPITAL AFTER EXPLANT. NO PATIENT COMPLICATIONS WERE NOTIFIED TO THE MANUFACTURER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6640378 ↗
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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