CARBOMEDICS ANNULOFLEXRecalls & reported problems across all models
Corcym Srl · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls
- 0
We found 6 models of CARBOMEDICS ANNULOFLEX by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 53 adverse event reports in the FDA's MAUDE database, received between Dec 2, 2016 and Apr 13, 2023 — classified as 51 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported CARBOMEDICS ANNULOFLEX problems
Device problems
- Insufficient Device Problem Information47
- Adverse Event Without Identified Device or Use Problem19
- Material Split, Cut or Torn2
- Appropriate Device Problem Term/Code Not Available1
- Inadequacy of Device Shape and/or Size1
- Patient-Device Incompatibility1
Patient problems
- No Information28
- Insufficient Information22
- Mitral Valve Stenosis4
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions3
- Dyspnea2
- Mitral Insufficiency2
- Heart Failure/Congestive Heart Failure1
CARBOMEDICS ANNULOFLEX models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CARBOMEDICS ANNULOFLEX AF-830RING, ANNULOPLASTY17 reports
- CARBOMEDICS ANNULOFLEX AF-832RING, ANNULOPLASTY11 reports
- CARBOMEDICS ANNULOFLEX AF-836RING, ANNULOPLASTY9 reports
- CARBOMEDICS ANNULOFLEX AF-834RING, ANNULOPLASTY8 reports
- CARBOMEDICS ANNULOFLEX AF-828RING, ANNULOPLASTY7 reports
- CARBOMEDICS ANNULOFLEX AF-826RING, ANNULOPLASTY1 report
Recent CARBOMEDICS ANNULOFLEX adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryDec 1, 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-832 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. 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 15900233 ↗InjuryDec 1, 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-832 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. 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 15899290 ↗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 ↗InjuryDec 24, 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, A ANNULOFLEX-SIZE 32 VALVE WAS IMPLANTED AND EXPLANTED ON (B)(6) 2021. THE MANUFACTURER DID NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION OR A SERIOUS INJURY FOR THE PATIENT FROM THE HOSPITAL REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 13085387 ↗InjuryDec 24, 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, A ANNULOFLEX-SIZE 32 VALVE WAS IMPLANTED AND EXPLANTED ON (B)(6) 2021. THE MANUFACTURER DID NOT RECEIVED ANY ALLEGATION OF A DEVICE MALFUNCTION OR A SERIOUS INJURY FOR THE PATIENT FROM THE HOSPITAL REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 13085276 ↗MalfunctionSep 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
ON (B)(6) 2021, AN ANNULOFLEX ANNULOPLASTY MITRAL RING AF-834 WAS ATTEMPTED TO BE IMPLANTED. THE ANNULOFLEX AF-834 WAS CUT AT ANTERIOR CUT POINTS BY THE SITE CV RESIDENT. FRAYING OCCURRED AT A3-P3 PORTION OF RING. THE RING WAS DISCARDED. ANOTHER AF-834 RING WAS OPENED AND THIS TIME THE SURGEON REMOVED ANTERIOR PORTION BY CUTTING ANNULOFLEX ANTERIOR CUT POINTS. THERE WAS NO FRAYING OF RING AND THIS RING WAS IMPLANTED WITH NO INCIDENT. THE PROCEDURE WENT WELL WITH 10 MINUTES INCREASE IN CROSS-CLAMP TIME. THE PATIENT HAD NORMAL RECOVERY. BASED ON THE INFORMATION REPORTED BY THE PHYSICIAN, THE EVENT MAY BE DUE TO USE ERROR OCCURRING AT THE TIME OF THE REMOVAL OF THE ANTERIOR PORTION OF THE RING. -
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12522347 ↗
Other Corcym Srl products
- CARBOMEDICS SUPRA-ANNULAR (TOP HAT)5 models · 99 reports
- PERCEVAL PLUS4 models · 92 reports
- CARBOMEDICS STANDARD12 models · 83 reports
- MEMO 3D7 models · 54 reports
- CARBOMEDICS REDUCED6 models · 39 reports
- CARBOMEDICS OPTIFORM6 models · 37 reports
- MEMO 3D RECHORD6 models · 36 reports
- Memo 4D7 models · 29 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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