MEMO 3D RECHORD MRCS32Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08022057015099), received between Dec 2, 2016 and Apr 12, 2022 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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.

• InjuryApr 12, 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, A MEMO 3D RECORD SEMIRIGID ANNULOPLASTY RING MRCS32 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2021. THE DEVICE WAS REPORTEDLY WASTED. 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 14089214 ↗
• InjuryJun 11, 2021Insufficient Device Problem Information; 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, A MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING SIZE 32 WAS IMPLANTED ON (B)(6) 2019. IT WAS EXPLANTED ON (B)(6)2021 AND REPLACED WITH A CARBOMEDICS OPTIFORM MITRAL HEART VALVE F7-029. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11982135 ↗
• InjuryJun 8, 2021Perivalvular Leak; Detachment of Device or Device Component; Insufficient Device Problem Information; Perivalvular Leak; Detachment of Device or Device Component; 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, A MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING SIZE 32 WAS IMPLANTED ON (B)(6) 2019. IT WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A CARBOMEDICS OPTIFORM MITRAL HEART VALVE F7-029. BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE OPERATIONAL REPORT, THE PATIENT PRESENTED PREVIOUS MITRAL VALVE STENOSIS AND INSUFFICIENCY AFTER PRIOR MITRAL VALVE AND HAD UNDERGONE A TRANSCATHETER MITRAL VALVE ( EDWARDS TRANSCATHETER VALVE LEADING TO A PARAVALVULAR LEAK). THE ANNULUS OF THE PREVIOUS ANNULOPLASTY RING HAD PULLED AWAY FROM THE POSTERIOR LEAFLET RESULTING IN A PARAVALVULAR LEAK. THE EDWARDS TRANSCATHETER VALVE AND THE MEMO 3D RING WERE EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A CARBOMEDICS OPTIFORM MITRAL HEART VALVE F7-029. THE PATIENTS MEDICAL HISTORY INCLUDES HODGKIN DISEASE, ACUTE-ON-CHRONIC CONGESTIVE HEART FAILURE, HYPERLIPIDEMIA, TRANSCATHETER MITRAL VALVE IN MITRAL VALVE RING ANNULUS AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. PATIENT WAS RETURNED TO ICU IN A STABLE CONDITION AND THEIR DISCHARGE CONDITION WAS GOOD. BASED ON INF

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 11962515 ↗
• InjuryApr 11, 2020Leak/Splash; Leak/Splash

  ON (B)(6) 2020 A PATIENT RECEIVED A MEMO-3D RECHORD MECHANICAL RING AS PART OF AN MITRAL VALVE REPAIR. THE MANUFACTURER WAS NOTIFIED THAT MITRAL REGURGITATION WAS OBSERVED, AND THE SITE RECOMMENDED RE-VALVULOPLASTY HOWEVER THE PATIENT WANTED TO REPLACE THE VALVE. ON (B)(6) 2020, MEMO 3D WAS EXPLANTED AND EPIC (29MM) WAS IMPLANTED. PATIENT WAS IN GOOD CONDITION AFTER OPERATION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9951720 ↗
• InjuryApr 11, 2020Leak/Splash; Leak/Splash

  ON (B)(6) 2020 A PATIENT RECEIVED A MEMO-3D RECHORD MECHANICAL RING AS PART OF AN MITRAL VALVE REPAIR. THE MANUFACTURER WAS NOTIFIED THAT MITRAL REGURGITATION WAS OBSERVED, AND THE SITE RECOMMENDED RE-VALVULOPLASTY HOWEVER THE PATIENT WANTED TO REPLACE THE VALVE. ON (B)(6) 2020, MEMO 3D WAS EXPLANTED AND EPIC (29MM) WAS IMPLANTED. PATIENT WAS IN GOOD CONDITION AFTER OPERATION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9951718 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A PATIENT WAS INTENDED TO RECEIVE A MEMO3D-RECHORD #32 ON (B)(6) 2019. THE MANUFACTURER WAS NOTIFIED THE DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9199904 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A PATIENT WAS INTENDED TO RECEIVE A MEMO3D-RECHORD #32 ON (B)(6) 2019. THE MANUFACTURER WAS NOTIFIED THE DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9199881 ↗
• DeathNov 23, 2017Material Deformation; Material Deformation

  ON (B)(6) 2017 A PATIENT DIED FROM HEART FAILURE AND "SYNDROME DE GLISSEMENT". EARLY DEGENERATION OF THE BIOPROSTHESIS WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Sudden Cardiac Death

  MAUDE report 7057203 ↗
• InjuryOct 6, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  AN ATTEMPT WAS MADE TO REPAIR THE MITRAL VALVE WITH A MEMO 3D ANNULOPLASTY RING, BUT THE SURGEON WAS NOT SATISFIED WITH THE REPAIR. HE DECIDED TO REPLACE THE MITRAL VALVE, AND IMPLANTED A MAGNA MITRAL VALVE SIZE 31 MM. THE PATIENT DID WELL, AND THE MEMO 3D WAS DISCARDED. THIS EVENT OCCURRED ON (B)(6) 2017. LIVANOVA CANADA CORP WAS NOTIFIED ON SEPTEMBER 6, 2017 OF THIS EVENT THROUGH PATIENT TRACKING.

  Patient problems: No Information

  MAUDE report 6921685 ↗
• InjurySep 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OH (B)(6) THE MANUFACTURER RECEIVED NOTIFICATION THROUGH PATIENT TRACKING OF A MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING THAT WAS IMPLANTED/EXPLANTED ON (B)(6) 2017 AND OF AN ANNULOFLEX MITRAL ANNULOPLASTY RING THAT WAS IMPLANTED ON (B)(6). ON FOLLOW UP WITH THE PHYSICIAN THE FOLLOWING EVENT DETAILS WERE CLARIFIED. THE FAILURE TO IMPLANT THE MEMO 3D RECHORD WAS DUE TO PHYSICIAN MEDICAL JUDGMENT DURING THE PROCEDURE THAT A MITRAL VALVE REPLACEMENT WAS REQUIRED. THE RING WAS EXPLANTED AND THE PHYSICIAN PERFORMED A MITRAL VALVE REPLACEMENT. THE ANNULOFLEX WAS IMPLANTED FOR A TRICUSPID ANNULOPLASTY. ADDITIONAL X CLAMP TIME WAS ADDED TO THE PROCEDURE FOR THE MITRAL VALVE REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6850482 ↗
• Dec 2, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON FELT THAT THE MEMO 3D RECHORD REPAIR WAS INSUFFICIENT AFTER DOING THE IMPLANT AND A RESECTION. HE DECIDED A REPAIR WAS NOT SUFFICIENT AND HE NEEDED TO REPLACE THE VALVE COMPLETELY. HE USED A MEDTRONIC MITRAL VALVE INSTEAD. THE PATIENT DID FINE AFTER THE REPLACEMENT.

  Patient problems: No Information

  MAUDE report 6142456 ↗