Memo 4D 4DM-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08022057015433), received between Mar 15, 2022 and Jan 16, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED OF A MEMO4D MITRAL RING, 4DM-30 EXPLANT. REPORTEDLY, THE DEVICE WAS IMPLANTED ON (B)(6) 2025, EXPLANTED ON (B)(6) 2025, AND MITRIS RESILIA WAS IMPLANTED INSTEAD. MANUFACTURER ATTEMPTED TO FOLLOW UP WITH THE SITE BUT WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED, AND THEY DO NOT THINK IT IS REALLY A COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 24099998 ↗
• InjuryMay 11, 2025Leak/Splash; Leak/Splash

  MANUFACTURER RECEIVED THE INFORMATION FROM DEVICE TRACKING DEPARTMENT. A MEMO 4D ANNULOPLASTY MITRAL REPAIR RING 4DM-30 WAS IMPLANTED IN A PATIENT ON (B)(6) 2021. A MITRAL VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 DUE TO THE MITRAL REGURGITATION. NO OTHER INFORMATION HAS YET BEEN RECEIVED FROM THE SITE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21999752 ↗
• InjuryMay 9, 2025Leak/Splash; Leak/Splash

  MANUFACTURER RECEIVED THE INFORMATION FROM DEVICE TRACKING DEPARTMENT. A MEMO 4D ANNULOPLASTY MITRAL REPAIR RING 4DM-30 WAS IMPLANTED IN A PATIENT ON (B)(6) 2021. A MITRAL VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 DUE TO THE MITRAL REGURGITATION. NO OTHER INFORMATION HAS YET BEEN RECEIVED FROM THE SITE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21997003 ↗
• InjuryNov 8, 2023Leak/Splash; Leak/Splash

  ON (B)(6) 2023, A MEMO4D RING SIZE 30 WAS ATTEMPTED TO BE IMPLANTED. AFTER DE-CLAMP, REGURGITATION DID NOT STOP. AS SUCH, THE DEVICE WAS EXPLANTED ON THE SAME DAY. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18096875 ↗
• InjuryOct 13, 2023Adverse 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 BECAME AWARE OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, ON (B)(6) 2023, A MEMO 4D ANNULOPLASTY RING SIZE 30 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. BASED ON THE FURTHER INFORMATION RECEIVED, THE RING WAS EXPLANTED DUE TO THE FAILED REPAIR AND WAS REPLACED WITH A VALVE. REPORTEDLY, THERE WAS NO PROBLEM WITH ANNULOPLASTY RING.

  Patient problems: Insufficient Information

  MAUDE report 17932271 ↗
• InjuryMar 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. BASED ON THE INFORMATION RECEIVED, MEMO 4D ANNULOPLASTY RING, SIZE 30 WAS IMPLANTED IN THE PATIENT THROUGH MINI-THORACOTOMY ON (B)(6) 2023.MEAN MITRAL GRADIENT AT THE TIME OF DISCHARGE WAS 7MMHG. REPORTEDLY, MITRAL VALVE ENDOCARDITIS, MODERATE TO SEVERE MI, AND RING DEHISCENCE WAS STARTED ON (B)(6) 2023. BASED ON THE INFORMATION AVAILABLE, MEDICATION WAS ADDED, AND MITRAL VALVE REPLACEMENT WAS PERFORMED ON (B)(6) 2023, AND THE ISSUE WAS RESOLVED. PATIENT HAS A HISTORY OF SYSTEMIC HYPERTENSION. FURTHERMORE, INFECTION DUE TO WOUND HEALING DISTURBANCE WAS REPORTED FOR THE PATIENT ON (B)(6)2023. BASED ON THE PATHOLOGY REPORT RECEIVED FROM THE HOSPITAL, PART OF THE SANDED MATERIAL WAS SUPERIMPOSED IN METHYL ACRYLATE. REPORTEDLY, CONSECUTIVE SECTIONS WERE USED FOR MICROSCOPIC ANALYSIS AND DNA EXTRACTION. THE FLUORESCENCE IN SITU HYBRIDIZATION (FISH) WAS PERFORMED WHICH LED TO DETECTION OF SEVERELY DEGRADED MICROORGANISMS INDIVIDUALLY IN THE TISSUE WITH THE NUCLEIC-SPECIFIC DYE DAPI. REPORTEDLY, NO ACTIVE BACTERIA WAS DETECTED IN THE FISH.

  Patient problems: Endocarditis; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16632775 ↗
• InjuryMar 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT REGISTRATION FORM, THE MEMO 4D SIZE 30 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY FOR THE PATIENT WAS RECEIVED FROM THE FIELD REGARDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 13765685 ↗
• InjuryMar 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION RECEIVED FROM THE PATIENT REGISTRATION FORM, THE MEMO 4D SIZE 30 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY FOR THE PATIENT WAS RECEIVED FROM THE FIELD REGARDING THIS EVENT.

  MAUDE report 13765656 ↗