CARBOMEDICS ANNULOFLEX AF-828Recalls & reported problems
Corcym Srl · Class 2 · Implant
All models of CARBOMEDICS ANNULOFLEX (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08022057013613), received between Jun 1, 2017 and Jan 3, 2020 — classified as 7 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).
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 Information7
- Adverse Event Without Identified Device or Use Problem2
- Patient-Device Incompatibility1
Patient problems
- No Information7
- Mitral Regurgitation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJan 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2019 A PATIENT WAS INTENDED TO RECEIVE A ANNULOFLEX AF-828 MECHANICAL MITRAL REPAIR RING. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Information
MAUDE report 9547519 ↗InjuryJan 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2019 A PATIENT WAS INTENDED TO RECIEVE A ANNULOFLEX AF-828 MECHANICAL MITRAL REPAIR RING. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION WAS RECEIVED.
Patient problems: No Information
MAUDE report 9547449 ↗InjuryApr 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED THAT AN ANNULEFLEX AF-828 WAS IMPLANTED (IN MITRAL POSITION) AND EXPLANTED ON (B)(6) 2019. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Information
MAUDE report 8476502 ↗InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO ANNULOFLEX MITRAL ANNULOPLASTY RING AF-828 IMPLANTED ON (B)(6) 2016. IT WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE M7-031 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Information
MAUDE report 8329335 ↗InjuryJun 7, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
AN ANNULOFLEX AF-828 (SN: (B)(4)) WAS IMPLANTED ON (B)(6) 2018. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS EXPLANTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: Mitral Regurgitation; No Information
MAUDE report 7579342 ↗InjuryJun 28, 2017Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON (B)(6) THE MANUFACTURER RECEIVED NOTIFICATION THROUGH PATIENT TRACKING OF AN ANNULOFLEX MITRAL ANNULOPLASTY RING THAT WAS IMPLANTED AND EXPLANTED ON (B)(6) 2017.
Patient problems: No Information
MAUDE report 6676004 ↗InjuryJun 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
MANUFACTURER WAS NOTIFIED THAT AN ANULOFLEX RING WAS IMPLANTED AND EXPLANTED ON (B)(6) 2017. TWO MORE DEVICES WERE ATTEMPTED DURING THE PROCEDURE: A MECHANICAL VALVE SZ 31 (IMPLANTED/EXPLANTED) AND SZ 29 (IMPLANTED). PATIENT CURRENTLY HAS THE MECHANICAL SZ 29 IMPLANTED.
Patient problems: No Information
MAUDE report 6606403 ↗
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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