CARBOMEDICS ANNULOFLEX AF-832Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08022057013637), received between Jun 28, 2017 and Dec 1, 2022 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMay 27, 2021Adverse 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 THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT.BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX ANNULOPLASTY RING AF-832 WAS IMPLANTED ON (B)(6) 2015. AS OF (B)(6) 2021, THE PATIENT IS REPORTED TO HAVE A MITRAL VALVE STENOSIS AND UNDERGOING AN EVALUATION FOR A RE-OPERATION. 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. THE MANUFACTURER HAS FOLLOWED UP AND RECEIVED THE FOLLOWING INFORMATION FROM THE HOSPITAL. THE PATIENT HAD A SURGERY IN 2015 WHERE ONE REPAIR AND ONE REPLACEMENT WAS PLANNED, BUT ULTIMATELY RECEIVED 2 VALVES (AORTIC AND MITRAL). THE PATIENT RECEIVED A 29MM ST JUDE EPIC VALVE IN MITRAL POSITION, WHICH REQUIRED A RE-INTERVENTION FOR MITRAL STENOSIS ON (B)(6) 2021. A TRANSCATHETER MITRAL VALVE REPLACEMENT WITH A 26-MM SAPIENS S3 VALVE WAS PERFORMED., WITH A GOOD OUTCOME.

  Patient problems: Insufficient Information; Mitral Valve Stenosis

  MAUDE report 11898692 ↗
• InjuryMay 27, 2021Adverse 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 THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX ANNULOPLASTY RING AF-832 WAS IMPLANTED ON (B)(6) 2015. AS OF (B)(6) 2021, THE PATIENT IS REPORTED TO HAVE A MITRAL VALVE STENOSIS AND UNDERGOING AN EVALUATION FOR A RE-OPERATION. 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. THE MANUFACTURER HAS FOLLOWED UP AND RECEIVED THE FOLLOWING INFORMATION FROM THE HOSPITAL. THE PATIENT HAD A SURGERY IN 2015 WHERE ONE REPAIR AND ONE REPLACEMENT WAS PLANNED, BUT ULTIMATELY RECEIVED 2 VALVES (AORTIC AND MITRAL). THE PATIENT RECEIVED A 29MM ST JUDE EPIC VALVE IN MITRAL POSITION, WHICH REQUIRED A RE-INTERVENTION FOR MITRAL STENOSIS ON (B)(6) 2021. A TRANSCATHETER MITRAL VALVE REPLACEMENT WITH A 26-MM SAPIENS S3 VALVE WAS PERFORMED., WITH A GOOD OUTCOME.

  Patient problems: Insufficient Information; Mitral Valve Stenosis

  MAUDE report 11898675 ↗
• InjurySep 16, 2020Adverse 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 RECEIVED INFORMATION ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX SIZE 32 IMPLANTED ON (B)(6) 2008 WAS EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: Dyspnea; Mitral Valve Stenosis; No Information

  MAUDE report 10544375 ↗
• InjurySep 16, 2020Adverse 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 RECEIVED INFORMATION ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, AN ANNULOFLEX SIZE 32 IMPLANTED ON (B)(6) 2008 WAS EXPLANTED ON (B)(6) 2020. THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT, IDENTIFYING THAT THE DIAGNOSIS WAS OF SEVERE MITRAL VALVE STENOSIS WITH A GRADIENT OF ABOUT 14 IN PREVIOUS MITRAL VALVE REPAIR. THE PATIENT DEVELOPED SHORTNESS OF BREATH. THE EXPLANTED MITRAL VALVE REPLACEMENT WITH A #29 CARBOMEDICS VALVE THROUGH MEDIAN STERNOTOMY. THE FINDINGS OF THE PROCEDURE WERE SEVERELY STENOTIC MITRAL VALVE WITH RING IN PLACE REQUIRING A REPLACEMENT. THE PROCEDURE WAS COMPLETED UNEVENTFULLY. NO FURTHER INFORMATION ON THE DEVICE DISPOSITION AFTER THE EXPLANT WAS PROVIDED.

  Patient problems: Dyspnea; Mitral Valve Stenosis; No Information

  MAUDE report 10544374 ↗
• InjuryDec 4, 2019Adverse 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) 2019 A PATIENT RECEIVED AN ANNULOFLEX AF-832 MITRAL REPAIR RING. THE MANUFACTURER WAS NOTIFIED THAT THE REPAIR ATTEMPT FAILED AND THE DEVICE WAS EXPLANTED. NO OTHER INFORMATION WAS PROVIDED. THE MANUFACTURER RECEIVED THE FOLLOWING UPDATED INFORMATION FROM THE SITE REGARDING THE EVENT ON (B)(6) 2020. PREOPERATIVE ASSESSMENT AND INDICATIONS FOR SURGERY. 83 YEAR OLD MALE PATIENT WITH A HISTORY OF CAD S/P LAD PCL/STENT, HTN, HLD, CKD, BPH, AND HYPOTHYROIDISM. PATIENT PRESENTED WITH ACUTE PULMONARY EDEMA WITH SOB AND ORTHOPNEA. HE WAS FOUND TO HAVE CUTE DIASTOLIC HF DUE TO SEVERE MR, TORN CHORDAE AND PARTIAL FLAIL OF P2.(NYHA III) HE WAS DIURESED AT OSH WITH IMPROVEMENT IN CARDIOPULM SYMPTOMS AND TRANSFERRED TO PPMC ON (B)(6) 2019 . SYMPTOMS DEVELOPED TWO TO THREE DAYS PRIOR TO ADMISSION. TEE PERFORMED REVEALED EF 60-65%, SEVERE MR, FLAILED MITRAL LEAFLEVP2. THERE WAS MODERATE LEAFLET CALCIFICATION OF THE AREA UNDER THE FLAIL SEGMENT. CARDIAC CATHETERIZATION REVEALED NO OBSTRUCTIVE CORONARY ARTERY DISEASE GREATER THAN 50%. THE LAD STENT WAS WIDELY PATENT. THERE WAS SEVERE CALCIFICATION IN THE CORONARIES. THERE WAS SEVERE MR ON V-GRAM WITH GOOD LV FUNCTION. AT TIME OF OPERATION

  Patient problems: Mitral Insufficiency; No Information

  MAUDE report 9413728 ↗
• InjuryDec 4, 2019Adverse 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) 2019 A PATIENT RECEIVED AN ANNULOFLEX AF-832 MITRAL REPAIR RING. THE MANUFACTURER WAS NOTIFIED THAT THE REPAIR ATTEMPT FAILED AND THE DEVICE WAS EXPLANTED. NO OTHER INFORMATION WAS PROVIDED. THE MANUFACTURER RECEIVED THE FOLLOWING UPDATED INFORMATION FROM THE SITE REGARDING THE EVENT ON (B)(6) 2020. PREOPERATIVE ASSESSMENT AND INDICATIONS FOR SURGERY. 83 YEAR OLD MALE PATIENT WITH A HISTORY OF CAD S/P LAD PCL/STENT, HTN, HLD, CKD, BPH, AND HYPOTHYROIDISM. PATIENT PRESENTED WITH ACUTE PULMONARY EDEMA WITH SOB AND ORTHOPNEA. HE WAS FOUND TO HAVE CUTE DIASTOLIC HF DUE TO SEVERE MR, TORN CHORDAE AND PARTIAL FLAIL OF P2.(NYHA III) HE WAS DIURESED AT OSH WITH IMPROVEMENT IN CARDIOPULM SYMPTOMS AND TRANSFERRED TO PPMC ON 09.11.2019 . SYMPTOMS DEVELOPED TWO TO THREE DAYS PRIOR TO ADMISSION. TEE PERFORMED REVEALED EF 60-65%, SEVERE MR, FLAILED MITRAL LEAFLEVP2. THERE WAS MODERATE LEAFLET CALCIFICATION OF THE AREA UNDER THE FLAIL SEGMENT. CARDIAC CATHETERIZATION REVEALED NO OBSTRUCTIVE CORONARY ARTERY DISEASE GREATER THAN 50%. THE LAD STENT WAS WIDELY PATENT. THERE WAS SEVERE CALCIFICATION IN THE CORONARIES. THERE WAS SEVERE MR ON V-GRAM WITH GOOD LV FUNCTION. AT TIME OF OPERATION

  Patient problems: Mitral Insufficiency; No Information

  MAUDE report 9413715 ↗
• InjuryJun 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2017 THE MANUFACTURER RECEIVED NOTIFICATION FROM PATIENT TRACKING OF AN ANNULOFLEX MITRAL ANNULOPLASTY RING THAT WAS IMPLANTED ON (B)(6) 2012 AND NOW WILL BE EXPLANTED/REPLACED BY A VALVE.

  Patient problems: No Information

  MAUDE report 6676037 ↗