MEMO 3D RECHORD MRCS30Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08022057015082), received between Apr 6, 2018 and Sep 29, 2021 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D RECHORD #30 VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION, PATIENT OUTCOME OR DEVICE FINALLY IMPLANTED WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 12551106 ↗
• InjurySep 29, 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 MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D RECHORD #30 VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION, PATIENT OUTCOME OR DEVICE FINALLY IMPLANTED WAS RECEIVED FROM THE SITE REGARDING THIS EVENT. THE MANUFACTURER OBTAINED ADDITIONAL INFORMATION IDENTIFYING THAT THE RING WAS EXPLANTED DUE TO A FAILED COMPLEX MITRAL VALVE REPAIR. THE EVENT WAS DEEMED NOT DEVICE RELATED BASED ON THE SURGEON'S ASSESSMENT.

  Patient problems: Insufficient Information

  MAUDE report 12551097 ↗
• InjuryOct 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS CLARIFIED THAT THE RING DEHISCENCE WAS FIRSTLY NOTICED ON (B)(6) 2019. THE REMAINDER OF THE INFORMATION IS UNCHANGED.

  Patient problems: No Information

  MAUDE report 9141101 ↗
• InjuryOct 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS CLARIFIED THAT THE RING DEHISCENCE WAS FIRSTLY NOTICED ON (B)(6) 2019. THE REMAINDER OF THE INFORMATION IS UNCHANGED.

  Patient problems: Congestive Heart Failure; No Information

  MAUDE report 9141031 ↗
• DeathApr 6, 2018Malposition of Device; Malposition of Device

  A PATIENT CAME WITH SEVERE HEART FAILURE AND PULMONARY EDEMA REQUIRED A MITRAL REPAIR SURGERY. A REPAIR OF THE MITRAL VALVE WAS PERFORMED USING THE MEMO 3D RECHORD AND AN ARTIFICIAL CHORD TIED TO THE CHORDAL GUIDING SYSTEM TO REPLACE A CHORDAE. ONCE THIS WAS TIED IT WAS NOTED THAT THE YELLOW LOOP OF THE CHORDAL GUIDING SYSTEM LOOKED "PULLED DOWN" AND THE CHORD APPEARED TO BE TOO SHORT. THE SURGEON DECIDED TO THEN REMOVE THE MEMO 3D RECHORD. THE PROCEDURE WAS CHANGED FROM A MITRAL REPAIR TO A FULL MITRAL VALVE REPLACEMENT. THE VALVE WAS REPLACED WITH A CARBOMEDICS STANDARD MITRAL VALVE. FOLLOWING SURGERY, THE PATIENT NEEDED TO BE PLACED ON ECMO. APPROXIMATELY TWO HOURS LATER THE PATIENT DIED. THE SURGEON REPORTS THAT THE DEATH WAS NOT DUE TO THE VALVES AND THAT THE PATIENT WAS VERY SICK.

  Patient problems: Death

  MAUDE report 7403820 ↗