Memo 4D 4DM-38Recalls & reported problems
Corcym Srl · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08022057015471), received between Apr 5, 2023 and Apr 5, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
Device problems
- Insufficient Device Problem Information1
Patient problems
- Myocardial Infarction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. BASED ON THE INFORMATION AVAILABLE, MEMO 4D SIZE 38 WAS IMPLANTED IN MITRAL POSITION DUE TO LEAFLET PROLAPSE, INSUFFICIENCY, CHORDAL FUSION, AND CHORDAL RUPTURE / FLAIL ON (B)(6) 2023 THROUGH MINI THORACOTOMY. PATIENT ALSO RECEIVED A SOVERING BAND SIZE 34 IN TRICUSPID POSITION ON THE SAME DAY. REPORTEDLY, ANNULAR DILATION WAS FOUND. BASED ON THE INFORMATION AVAILABLE, PATIENT WAS PRESENTED WITH MYOCARDIAL INFARCTION AND OCCLUSION OF THE CIRCUMFLEX ARTERY ON THE SAME DAY. REPORTEDLY, THE ACTION TAKEN WAS CABG OF THE OCCLUDED CIRCUMFLEX ARTERY, AND TRANSFUSION. FURTHER EXAMS AND TESTS WERE ALSO PERFORMED. THE OUTCOME OF THE EVENT WAS REPORTED AS RECOVERED/RESOLVED. BASED ON THE INFORMATION IN THE DATABASE, PATIENT HAS A HISTORY OF PERSISTENT ARRHYTHMIA, SYSTEMIC HYPERTENSION, DYSLIPIDEMIA, AND IS ASSESSED AS NYHA CLASS I. BASED ON THE SITE'S ASSESSMENT, CAUSE OF THE EVENT WAS POSSIBLY RELATED TO MEMO 4D, INITIAL IMPLANT PROCEDURE, PRIMARY CONDITION BEING TREATED AND DEFINITELY RELATED TO CONCOMITANT MEDICATION.
Patient problems: Myocardial Infarction
MAUDE report 16685648 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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