Memo 4D 4DM-36Recalls & reported problems
Corcym Srl · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08022057015464), received between Jul 16, 2025 and Sep 27, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Endocarditis1
- Insufficient Information1
- Transient Ischemic Attack1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50909498 ↗InjuryJul 16, 2025Adverse 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 THROUGH THE MANTRA STUDY OF AN EARLY EXPLANT OF A MEMO 4D ANNULOPLASTY RING THAT TOOK PLACE ON (B)(6) 2025. BASED ON THE INFORMATION AVAILABLE IN THE STUDY DATABASE, THE DEVICE HAD BEEN IMPLANTED WITHOUT REPORTED COMPLICATIONS ON (B)(6) 2025 THROUGH MINI THORACOTOMY, IN A NYHA CLASS II PATIENT AFFECTED BY BARLOW DISEASE WITH TYPE II POSTERIOR LEAFLET PROLAPSE AND CHORDAE ELONGATION. AS REPORTED, ON (B)(6) 2025 THE PATIENT WAS DIAGNOSED WITH MITRAL VALVE ENDOCARDITIS WITH ASSOCIATED VEGETATIONS, WHICH, BASED ON THE SITE'S ASSESSMENT, LIKELY RESULTED IN A TRANSIENT ISCHEMIC ATTACK (TIA). AS A RESULT, THE MEMO 4D RING WAS EXPLANTED DURING A RE-INTERVENTION PERFORMED VIA MINIMALLY INVASIVE SURGERY. THE PATIENT HAS REPORTEDLY RECOVERED, AND THE INFECTION HAS BEEN RESOLVED. ACCORDING TO FURTHER INFORMATION AVAILABLE IN THE STUDY DATABASE, THE MITRAL REPAIR PROCEDURE HAD BEEN EXECUTED AS A STAND-ALONE SURGERY TO CORRECT SEVERE MITRAL REGURGITATION AND POSTERIOR CHORDAE HAD BEEN REPLACED, WITH TWO ATTACHING POINTS ON THE LEAFLET EDGE. PRE-OPERATIVE ECHOCARDIOGRAPHIC ASSESSMENT PERFORMED IN (B)(6) 2024 HAD SHOWN A LEFT VENTRICULAR END-DIASTOLIC VOLUME (LVEDV) O
Patient problems: Endocarditis; Transient Ischemic Attack
MAUDE report 22520814 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.