CARBOMEDICS ANNULOFLEX AF-830Recalls & 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
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08022057013620), received between Aug 10, 2017 and Apr 13, 2023 — classified as 17 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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 Information16
- Adverse Event Without Identified Device or Use Problem5
Patient problems
- Insufficient Information12
- No Information5
- Heart Failure/Congestive Heart Failure1
- Mitral Valve Insufficiency/ Regurgitation1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE PATIENT REGISTRATION FORM (PRF) RECEIVED, AN ANNULOFLEX MITRAL ANNULOPLASTY RING, AF-830, WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2023 IN A PATIENT. NO ALLEGATION OF DEVICE MALFUNCTION NOR THE SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 16736442 ↗InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE PATIENT REGISTRATION FORM (PRF) RECEIVED, AN ANNULOFLEX MITRAL ANNULOPLASTY RING, AF-830, WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2023 IN A PATIENT. NO ALLEGATION OF DEVICE MALFUNCTION NOR THE SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT. BASED ON THE FURTHER INFORMATION RECEIVED, RING WAS EXPLANTED DUE TO THE SAM. REPORTEDLY, NO MALFUNCTION WITH THE DEVICE WAS NOTED AND THE OUTCOME OF THE PATIENT IS GOOD.
Patient problems: Insufficient Information
MAUDE report 16736414 ↗InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, AN ANNULOFLEX MITRAL ANNULOPLASTY RING AF-830 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT REGARDING THIS EVENT HAS BEEN RECEIVED FORM THE HOSPITAL.
Patient problems: Insufficient Information
MAUDE report 14706114 ↗InjuryJun 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT.BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, AN ANNULOFLEX MITRAL ANNULOPLASTY RING AF-830 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT REGARDING THIS EVENT HAS BEEN RECEIVED FORM THE HOSPITAL.
Patient problems: Insufficient Information
MAUDE report 14706093 ↗InjuryMay 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, ON (B)(6) 2022, ANNULOFLEX MITRAL RING AF-830 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. ANOTHER AF-830 WAS IMPLANTED IN THE PATIENT AS A REPLACEMENT. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE HOSPITAL REGRADING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14545144 ↗InjuryMay 30, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION ON THE PATIENT IMPLANT FORM, ON (B)(6) 2022, ANNULOFLEX MITRAL RING AF-830 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. ANOTHER AF-830 WAS IMPLANTED IN THE PATIENT AS A REPLACEMENT. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE HOSPITAL REGRADING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14545142 ↗InjuryMay 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT IMPLANT FORM, ANNULOFLEX MITRAL ANNULOPLASTY RING AF-830 WHICH WAS IMPLANTED ON (B)(6) 2011, WAS EXPLANTED ON (B)(6) 2022. A CARBOMEDICS STANDARD MITRAL PROSTHETIC HEART VALVE M7-023 WAS IMPLANTED IN THE PATIENT AS A REPLACEMENT. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF SERIOUS INJURY FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14282935 ↗InjuryMay 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT IMPLANT FORM, ANNULOFLEX MITRAL ANNULOPLASTY RING AF-830 WHICH WAS IMPLANTED ON (B)(6) 2011, WAS EXPLANTED ON (B)(6) 2022. A CARBOMEDICS STANDARD MITRAL PROSTHETIC HEART VALVE M7-023 WAS IMPLANTED IN THE PATIENT AS A REPLACEMENT. THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF SERIOUS INJURY FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14282838 ↗InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; 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 ANNULOFLEX MITRAL ANNULOPLASTY RING AF-830 WAS IMPLANTED ON (B)(6) 2016. THE DEVICE WAS REPLACED WITH CARBOMEDICS STANDARD MECHANICAL HEART VALVE M7-031 ON (B)(6) 2021 (AFTER > 5 YEARS). THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF SERIOUS INJURY FROM THE SITE REGARDING THIS EVENT.
Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation
MAUDE report 14017411 ↗InjuryApr 5, 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 ANNULOFLEX MITRAL ANNULOPLASTY RING AF-830 WAS IMPLANTED ON (B)(6) 2016. THE DEVICE WAS REPLACED WITH CARBOMEDICS STANDARD MECHANICAL HEART VALVE M7-031 ON (B)(6) 2021 (AFTER > 5 YEARS). THE MANUFACTURER HAS NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION NOR OF SERIOUS INJURY FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14017406 ↗InjuryJun 16, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX RING AF-830 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 12009388 ↗InjuryJun 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT.BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX RING AF-830 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 12005842 ↗InjuryMar 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2019, AN IMPLANT ATTEMPT OF AN ANNULOFLEX SIZE 30 RING (AF-830) AND AN ANNULOFLEX SIZE 28 (AF-828) OCCURRED. HOWEVER, IT IS REPORTED THAT THE RINGS WERE IMPLANTED, EXPLANTED AND WASTED. NO OTHER INFORMATION IS CURRENTLY AVAILABLE.
Patient problems: No Information
MAUDE report 8384226 ↗InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO ANNULOFLEX MITRAL ANNULOPLASTY RING AF-830 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE M7-029 ON (B)(6) 2015. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Information
MAUDE report 8333938 ↗InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO ANNULOFLEX MITRAL ANNULOPLASTY RING AF-830 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH AN OPTIFORM PROSTHETIC MITRAL HEART VALVE F7-031 ON (B)(6) 2014. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.
Patient problems: No Information
MAUDE report 8333409 ↗InjuryMar 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN ANNULOFLEX MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED ON (B)(6) 2018. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Information
MAUDE report 7383008 ↗InjuryAug 10, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ON (B)(6) 2017 THE MANUFACTURER RECEIVED NOTIFICATION THROUGH PATIENT TRACKING OF AN ANNULOFLEX MITRAL ANNULOPLASTY RING THAT WAS 'WASTED' ON (B)(6) 2017.
Patient problems: No Information; No Known Impact Or Consequence To Patient
MAUDE report 6786943 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page