MEMO 3D SMD32Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08022057013132), received between Oct 19, 2016 and Sep 6, 2024 — classified as 1 death, 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH COMPETITOR'S PATIENT TRACKING. BASED ON THE INFORMATION RECEIVED, THE MEMO 3D RING ICV0970 WAS IMPLANTED IN A PATIENT ON (B)(6) 2023. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2023 AND REPLACED WITH PHYSIO II 30MM. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20161219 ↗
• DeathApr 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED THROUGH MANTRA STUDY THAT A PATIENT IMPLANTED WITH A MEMO 3D SIZE 32 MITRAL ANNULOPLASTY RING PASSED AWAY ON (B)(6) 2022. THE EVENT WAS A SUDDEN DEATH OCCURRING DURING THE NIGHT WHILE THE PATIENT WAS SLEEPING. THE RING HAD BEEN IMPLANTED ON (B)(6) 2021 THROUGH MEDIAN STERNOTOMY AND CONCOMITANT CABG HAD BEEN PERFORMED IN THE SAME SURGERY PRIOR TO RING IMPLANTATION. THE PATIENT WAS IN PARTICULARLY COMPLEX HEALTH CONDITIONS AND SUFFERED FROM BRONCHOPATHY WITH SLEEP APNEA. HE HAD A PREVIOUS HISTORY OF CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION (<= 90 DAYS AT THE TIME OF SURGERY), ISCHEMIC HEART FAILURE, DIABETES MELLITUS TYPE II, DYSLIPIDEMIA. HE ALSO HAD A TOBACCO HISTORY AND WAS NYHA CLASS III.

  Patient problems: Heart Failure/Congestive Heart Failure; Myocardial Infarction

  MAUDE report 16782945 ↗
• InjuryNov 4, 2020Insufficient 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 SMD32 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 10787766 ↗
• InjuryNov 4, 2020Insufficient 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 SMD32 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

  Patient problems: No Information

  MAUDE report 10787723 ↗
• InjuryApr 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

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. ON (B)(6) 2020, A MEMO 3D #32 WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NO COMPLAINT RECEIVED FROM THE SITE REGARDING THIS EVENT.

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

  MAUDE report 9944205 ↗
• InjuryApr 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

  THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. ON 07 FEB 2020, A MEMO 3D #32 WAS IMPLANTED AND EXPLANTED INTRAOPERATIVELY. NO COMPLAINT RECEIVED FROM THE SITE REGARDING THIS EVENT. PER ADDITIONAL INFORMATION RECEIVED, THE RING WAS EXPLANTED INTRAOPERATIVELY DUE TO A FAILED REPAIR, ULTIMATELY CONVERTED TO A FULL VALVE REPLACEMENT. THE RING WAS DISCARDED. THE PRE-OPERATIVE DIAGNOSIS WAS OF SEVERE, SYMPTOMATIC MITRAL INSUFFICIENCY. THE OP NOTE REPORTS THAT THERE WAS A RUPTURED P2 CHORD, AND A REPAIR OF THE VALVE WAS INITIALLY ATTEMPTED TO AMELIORATE THE INSUFFICIENCY. AFTER THE IMPLANT OF THE 32 MEMO 3D RING, "SALINE TESTING AT THIS POINT SHOWED THAT THERE WAS AN ASYMMETRIC BILLOWING OF A1 AND A2 THAT HAD NOT BEEN APPRECIATED AND THERE WAS A SIGNIFICANT LEAK. THE RING WAS REMOVED AND THE ANTERIOR LEAFLET EXCISED. A 31 MM MEDTRONIC MOSAIC PORCINE TISSUE VALVE WAS IMPLANTED". THE PATIENT WAS NOT ADVERSELY IMPACTED BY THE EVENT BASED ON THE REPORT RECEIVED.

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

  MAUDE report 9944196 ↗
• InjuryApr 1, 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. PER THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, ON (B)(6) 2020 A PATIENT RECEIVED A MEMO 3D #32 IN MITRAL POSITION. THE DEVICE WAS EXPLANTED INTRAOPERATIVELY. NO OTHER INFORMATION IS PRESENTLY AVAILABLE. NO COMPLAINT HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT.

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

  MAUDE report 9912435 ↗
• InjuryApr 1, 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. PER THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, ON (B)(6) 2020 A PATIENT RECEIVED A MEMO 3D #32 IN MITRAL POSITION. THE DEVICE WAS EXPLANTED INTRAOPERATIVELY. NO OTHER INFORMATION IS PRESENTLY AVAILABLE. NO COMPLAINT HAS BEEN RECEIVED FROM THE SITE REGARDING THIS EVENT.

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

  MAUDE report 9912377 ↗
• InjuryAug 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MEMO 3D, SIZE (B)(6) WAS IMPLANTED AND EXPLANTED ON (B)(6) 2018. THE SURGEON IMPLANTED THE DEVICE, REALIZED IT WAS TOO SMALL, AND REPLACED IT WITH A SIZE (B)(6). IT WAS REPORTED THAT THERE WAS NOTHING WRONG WITH THE DEVICE, OR ANY HARM TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 7740052 ↗
• InjuryMay 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2008 A MEMO 3D SIZE 32 MECHANICAL MITRAL REPAIR RING WAS IMPLANTED. ON (B)(6) 2018 A CARBOMEDICS M7-027 STANDARD MITRAL VALVE WAS IMPLANTED. NO FURTHER EVENT INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 7535329 ↗
• InjuryNov 28, 2017Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  A MEMO3D RECHORD WAS IMPLANTED AND EXPLANTED ON (B)(6) 2017. THE SURGEON INDICATED THAT NOTHING WAS WRONG WITH THE RING. RATHER, HE CHOSE TO REPLACE THE MITRAL VALVE AFTER FIRST ATTEMPTING TO REPAIR THE VALVE WITH THE MEMO RING.

  Patient problems: No Information

  MAUDE report 7065644 ↗
• InjuryApr 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED FROM PATIENT REGISTRATION FORM THAT THE PATIENT HAD A MITRAL REPAIR SURGERY ON (B)(6) 2017 AND ON (B)(6) 2017 UNDERWENT A SECOND MITRAL REPAIR SURGERY WITH A SMALLER SIZE RING. IT WAS STATED THAT THE INCORRECT SIZE REPAIR (TOO LARGE) WAS IMPLANTED WHICH LED TO MODERATE TO SEVERE MITRAL REGURGITATION. THE RING WAS REPLACED WITH A SMALLER RING WHICH RESOLVED THE ISSUE. THE RING WAS DISCARDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6528147 ↗
• InjuryOct 19, 2016Adverse Event Without Identified Device or Use Problem

  PT (B)(6) RECEIVED A PRF FOR A MITRAL RING SMD32 SN # (B)(4) WHICH WAS REMOVED ON (B)(6) 2016 AT (B)(6) MEDICAL CENTER. PATIENT (B)(6) IS MALE, DOB (B)(6) 1947. UPDATE FROM SALES 29 SEPT 2016: DR (B)(6) WAS OPERATING SURGEON. HE PLACED THE 32 RING INTO THE PATIENT. WHEN COMING OFF BYPASS AND POST TEE PERFORMED, SEVERE MR WAS NOTED. WENT BACK ONTO BYPASS, REMOVED THE RING AND REPLACED WITH AN EDWARD'S TISSUE VALVE. PATIENT HAD AN EXTENDED POST OP RECOVERY INCLUDING LONG INTUBATION TIME, POST OP ACUTE RENAL FAILURE, ELEVATED LIVER FUNCTIONS AND A STROKE. PATIENT WAS DISCHARGED AFTER 14 DAYS TO A REHAB FACILITY.

  Patient problems: Mitral Regurgitation

  MAUDE report 6041602 ↗