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CARBOMEDICS ANNULOFLO AR-736Recalls & 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 08022057013712), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, AN ANNULOFLO MITRAL ANNULOPLASTY RING AR-736 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF SERIOUS INJURY FROM THE SITE REGARDING THIS EVENT.

    MAUDE report 13765502 ↗

Other RING, ANNULOPLASTY devices

All RING, ANNULOPLASTY devices →

Sources and updates

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