MEMO 3D SMD30Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08022057013125), received between Jun 9, 2017 and May 19, 2023 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURE WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A PATIENT RECEIVED A MEMO 3D SEMIRIGID ANNULOPLASTY RING, SMD30 IN MITRAL POSITION ON (B)(6) 2022. REPORTEDLY, THE RING WAS EVENTUALLY REPLACED WITH OPTIFORM PROSTHETIC MITRAL HEART VALVE SIZE 29MM ON (B)(6) 2023. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 16970116 ↗
• InjuryMay 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURE WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A PATIENT RECEIVED A MEMO 3D SEMIRIGID ANNULOPLASTY RING, SMD30 IN MITRAL POSITION ON (B)(6) 2022. REPORTEDLY, THE RING WAS EVENTUALLY REPLACED WITH OPTIFORM PROSTHETIC MITRAL HEART VALVE SIZE 29MM ON (B)(6) 2023. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE.

  Patient problems: Insufficient Information

  MAUDE report 16963359 ↗
• InjuryApr 1, 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 #30 DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. ANOTHER MEMO 3D #30 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION OR PATIENT OUTCOME WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11605937 ↗
• InjuryApr 1, 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 #30 DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. ANOTHER MEMO 3D #30 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION OR PATIENT OUTCOME WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11605936 ↗
• InjuryOct 9, 2020Adverse 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) 2020 A PATIENT WAS INTENDED TO RECEIVE A MEMO 3D 30MM MECHANICAL MITRAL REPAIR RING AS PART OF AN MVR TO TREAT A PATIENT WITH MITRAL REGURGITATION DUE TO INFECTIVE ENDOCARDITIS. THE MANUFACTURER WAS NOTIFIED THAT THE REGURGITATION DID NOT STOP AND THE PRODUCT WAS EXPLANTED INTRA-OPERATIVELY AND REPLACED WITH ANOTHER PRODUCT. THERE WAS A TEAR IN THE COMMISSURE PORTION OF THE RCC AND NCC CAUSING REGURGITATION. THE PATIENT IS STILL BEING TREATED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Mitral Regurgitation

  MAUDE report 10659774 ↗
• InjuryOct 9, 2020Adverse 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) 2020 A PATIENT WAS INTENDED TO RECEIVE A MEMO 3D 30MM MECHANICAL MITRAL REPAIR RING AS PART OF AN MVR TO TREAT A PATIENT WITH MITRAL REGURGITATION DUE TO INFECTIVE ENDOCARDITIS. THE MANUFACTURER WAS NOTIFIED THAT THE REGURGITATION DID NOT STOP AND THE PRODUCT WAS EXPLANTED INTRA-OPERATIVELY AND REPLACED WITH ANOTHER PRODUCT. THERE WAS A TEAR IN THE COMMISSURE PORTION OF THE RCC AND NCC CAUSING REGURGITATION. THE PATIENT IS STILL BEING TREATED. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Mitral Regurgitation

  MAUDE report 10659772 ↗
• InjuryJul 11, 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) 2018 A PATIENT RECEIVED A MEMO 3D SMD30 MITRAL REPAIR RING. THE MANUFACTURER WAS NOTIFIED THAT THE RING WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD M7-027 MECHANICAL MITRAL VALVE ON (B)(6) 2019. THE EVENT OCCURRED AT (B)(6) HOSPITAL (B)(6) AND INVOLVED DR. (B)(6). NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 8782338 ↗
• InjuryJul 11, 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) 2018 A PATIENT RECEIVED A MEMO 3D SMD30 MITRAL REPAIR RING. THE MANUFACTURER WAS NOTIFIED THAT THE RING WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD M7-027 MECHANICAL MITRAL VALVE ON (B)(6) 2019. THE EVENT OCCURRED AT (B)(6) AND INVOLVED DR. (B)(6). NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 8782259 ↗
• InjuryJun 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2019 A PATIENT RECEIVED A MEMO-3D, ICV0969, MITRAL REPAIR RING. ON (B)(6) 2019 THE RING WAS EXPLANTED AND REPLACED WITH A MEMO RECHORD MRCS32 MITRAL REPAIR RING. THE EVENT OCCURRED AT (B)(6) HOSP (B)(6), AND INVOLVED DR. (B)(6).

  Patient problems: No Information

  MAUDE report 8710307 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO MEMO 3D SEMIRIGID ANNULOPLASTY RING # 30 / ICV0969 IMPLANTED ON (B)(6) 2014 IN MITRAL POSITION. IT WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE M7-027 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8329858 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO MEMO 3D SEMIRIGID ANNULOPLASTY RING # 30 / ICV0969 IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE M7-027 ON (B)(6) 2015. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8329655 ↗
• InjuryFeb 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO MEMO 3D SEMIRIGID ANNULOPLASTY RING # 30/ICV0969 IMPLANTED ON (B)(6) 2015. IT WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE M7-031 ON (B)(6) 2015. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8324326 ↗
• InjuryDec 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 A PATIENT RECEIVED A MEMO 3D SMD30, MECHANICAL MITRAL REPAIR RING. THE MANUFACTURER WAS NOTIFIED THAT THE RING WAS EXPLANTED THE SAME DAY ((B)(6) 2018). THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE SITE ON FEBRUARY 11, 2019. THE RING WAS NEVER ACTUALLY IMPLANTED IN THE PATIENT AS THE SURGEON CHANGED THEIR MIND AND IMPLANTED A TISSUE VALVE INSTEAD. THIS WAS AN EDWARDS MAGNA EASE. THERE WAS NO FAULT WITH THE RING.

  Patient problems: No Information

  MAUDE report 8177240 ↗
• InjuryOct 10, 2017Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON (B)(6) 2017 THE MANUFACTURER WAS NOTIFIED THROUGH PATIENT TRACKING OF MEMO 3D SIZE 30 (SN# (B)(4) THAT WAS IMPLANTED AND EXPLANTED ON THE SAME DAY (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS NOT SUITABLE FOR A REPAIR, REGARDLESS OF THE TYPE OF MITRAL RING.

  Patient problems: No Information

  MAUDE report 6933813 ↗
• InjurySep 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER RECEIVED NOTIFICATION FROM PATIENT TRACKING ON (B)(6) 2017 OF THE FOLLOWING: ON (B)(6) A MEMO 3D SEMIRIGID ANNULOPLASTY RING (SIZE 30, SN# (B)(4)) WAS IMPLANTED/EXPLANTED AND A CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL (M7-027 SN# (B)(4)) WAS THEN IMPLANTED SAME DAY.

  Patient problems: No Information

  MAUDE report 6850543 ↗
• InjuryAug 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JULY 28TH THE MANUFACTURER RECEIVED NOTIFICATION THROUGH PATIENT TRACKING OF AN EVENT THAT OCCURRED ON (B)(6) FOR A MEMO 3D SEMIRIGID ANNULOPLASTY RING THAT WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO THE MANUFACTURER.

  Patient problems: No Information

  MAUDE report 6821660 ↗
• InjuryJun 9, 2017Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2017, THE MANUFACTURER WAS NOTIFIED THAT A MEMO 3D SEMIRIGID RING WAS ATTEMPTED TO BE IMPLANTED WITHOUT SUCCESS ON (B)(6) 2017. MEDTRONIC TISSUE VALVE WAS USED INSTEAD. THIRTY MIN OF EXTRA X-CLAMP TIME WAS ADDED TO THE PROCEDURE. PATIENT WAS DISCHARGED AND IS DOING WELL. THE SURGEON STATED THAT THE PATIENT ANNULUS ANATOMY WAS NOT SUITABLE FOR A VALVE REPAIR.

  Patient problems: No Information

  MAUDE report 6632593 ↗