MEMO 3D SMD28Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08022057013118), received between Apr 24, 2017 and May 27, 2021 — classified as 12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D SEMIRIGID ANNULOPLASTY RING SMD28 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2021. 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: Insufficient Information

  MAUDE report 11898182 ↗
• InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  SEE INITIAL REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11898159 ↗
• InjurySep 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A MEMO 3D SMD28 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY, (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: No Information

  MAUDE report 10525538 ↗
• InjurySep 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A MEMO 3D SMD28 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY, (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE.

  Patient problems: No Information

  MAUDE report 10525533 ↗
• InjuryApr 8, 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 WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING TEAM.BASED ON THE INFORMATION AVAILABLE ON THE PATIENT IMPLANT FORM, ON (B)(6) 2019, A MEMO3D #28 WAS IMPLANTED/EXPLANTED INTRAOPERATIVELY. NO FURTHER INFORMATION ON THE EVENT OR ON THE DEVICE DISPOSITION IS PRESENTLY AVAILABLE. NO COMPLAINT HAS BEEN RECEIVED FROM THE SITE PERTAINING TO THIS EVENT.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9936488 ↗
• InjuryApr 8, 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 WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING TEAM. BASED ON THE INFORMATION AVAILABLE ON THE PATIENT IMPLANT FORM, ON (B)(6) 2019, A MEMO3D #28 WAS IMPLANTED/EXPLANTED INTRAOPERATIVELY. NO COMPLAINT HAS BEEN RECEIVED FROM THE SITE PERTAINING TO THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED, THE RING WAS EXPLANTED INTRAOPERATIVELY DUE TO A FAILED REPAIR, AND THE PROCEDURE WAS CONVERTED TO A FULL VALVE REPLACEMENT WITH A BIOPROSTHETIC VALVE (31MM MOSAIC TISSUE VALVE). THE RING WAS DISCARDED. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS BASED ON THE INFORMATION RECEIVED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9936446 ↗
• InjurySep 24, 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 A MEMO 3D SEMIRIGID ANNULOPLASTY RING, SMD28, ICV0968, AS PART OF A MITRAL VALVE REPAIR. THE MANUFACTURER WAS NOTIFIED THAT THE SAME DAY THE DEVICE WAS EXPLANTED AND REPLACED WITH A SECOND MEMO 3D, HOWEVER THE SIZE WAS INCREASED TO A SMD32, ICV0970. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9113007 ↗
• InjurySep 24, 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 A MEMO 3D SEMIRIGID ANNULOPLASTY RING, SMD28, ICV0968, AS PART OF A MITRAL VALVE REPAIR. THE MANUFACTURER WAS NOTIFIED THAT THE SAME DAY THE DEVICE WAS EXPLANTED AND REPLACED WITH A SECOND MEMO 3D, HOWEVER THE SIZE WAS INCREASED TO A SMD32, ICV0970. NO FURTHER INFORMATION WAS RECEIVED. THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION RECEIVED ON SEP 27 2019 IDENTIFYING THE ORIGINAL REPAIR DIDN'T WORK AS INTENDED SO THE SURGEON CHOSE A LARGER SIZE MEMO TO CREATE THE CORRECT REPAIR. NO ALLEGATIONS WERE MADE AGAINST THE ORIGINAL DEVICE. IT WAS REGARDED AS SIMPLY A CORRECTED MV REPAIR.

  Patient problems: No Information

  MAUDE report 9112927 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS NOTIFIED THAT ON (B)(6) 2018 A MEMO3D SMD28 WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 8356369 ↗
• InjuryFeb 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON CAPA (B)(4) INVESTIGATION: THIS EVENT REFERS TO MEMO 3D SEMIRIGID ANNULOPLASTY RING # 28 / ICV0968 IMPLANTED ON (B)(6) 2015 IN MITRAL POSITION. IT WAS EXPLANTED AND REPLACED WITH A CARBOMEDICS STANDARD PROSTHETIC MITRAL HEART VALVE M7-025 ON (B)(6) 2016. NO FURTHER EVENT DETAILS WERE PROVIDED AND DEVICE WAS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Information

  MAUDE report 8333872 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON 30 MAY 2017 THE MANUFACTURER RECEIVED NOTIFICATION THROUGH PATIENT TRACKING OF A MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING THAT WAS IMPLANTED/EXPLANTED ON (B)(6) 2017.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6676029 ↗
• InjuryApr 24, 2017Adverse 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) 2017 DURING A MITRAL VALVE REPAIR PROCEDURE, THE FAILURE TO IMPLANT THE MEMO 3D WAS DUE TO PHYSICIAN MEDICAL JUDGMENT DURING THE PROCEDURE THAT A MITRAL VALVE REPLACEMENT WAS REQUIRED AND. AS PER MEDICAL JUDGMENT NO ISSUE WITH THE MEMO 3D DEVICE. THE RING WAS REMOVED AND THE PHYSICIAN PERFORMED A MITRAL VALVE REPLACEMENT. THE DEVICE HAS BEEN DISCARDED BY THE HOSPITAL.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6517037 ↗