Memo 4D 4DM-34Recalls & reported problems
Corcym Srl · Class 2 · Implant
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08022057015457), received between Jul 11, 2022 and Aug 28, 2026 — classified as 8 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 Information7
- Leak/Splash3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information7
- Mitral Valve Insufficiency/ Regurgitation2
- Aortic Valve Insufficiency/ Regurgitation1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Insufficient Device Problem Information
The manufacturer was notified of an intraoperative explant involving a MEMO 4D Annuloplasty Repair Ring. Based on the information available to the manufacturer from the Patient Tracking audit. On (B)(6) 2024, a MEMO 4D Annuloplasty Repair Ring size 34 was implanted and explanted during the same day and the device was reported as "wasted". No further details about the event, device or patient have been received from the site at this time.
Patient problems: Insufficient Information
MAUDE report 50500692 ↗MalfunctionMay 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
MANUFACTURER WAS INFORMED THAT ON (B)(6) 2023, AN INTRA-OPERATIVE EXPLANT OF MEMO 4D REPAIR RING 4DM-34 OCCURRED. REPORTEDLY, SIMILAR DEVICE OF THE SAME SIZE WAS IMPLANTED AS A REPLACEMENT IN THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22074123 ↗MalfunctionMar 19, 2025Leak/Splash; Leak/Splash
ON (B)(6) 2025, A MEMO4D ANNULOPLASTY REPAIR RING 4DM-34 WAS IMPLANTED IN THE PATIENT. AFTER DE-CLAMPED, REGURGITATION WAS NOTED, THE DEVICE WAS EXPLANTED, AND ANOTHER SIMILAR RING MEMO 4DM-34 WAS IMPLANTED INSTEAD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 21649656 ↗InjuryAug 11, 2023Insufficient Device Problem Information; 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 34 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY DUE TO UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME AND NO INDICATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE.
Patient problems: Insufficient Information
MAUDE report 17515630 ↗InjuryMar 27, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER RECEIVED THE FOLLOWING INFORMATION THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A MEMO4D ANNULOPLASTY RING SIZE 34 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2021 . REPORTEDLY, THE PATIENT WAS SCHEDULED FOR A MITRAL VALVE IN RING RE-INTERVENTION PROCEDURE DUE TO LEAKAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 16623815 ↗InjuryMar 27, 2023Leak/Splash; Leak/Splash
THE MANUFACTURER RECEIVED THE FOLLOWING INFORMATION THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A MEMO4D ANNULOPLASTY RING SIZE 34 WAS IMPLANTED IN THE PATIENT ON (B)(6) 2021. REPORTEDLY, THE PATIENT WAS SCHEDULED FOR A MITRAL VALVE IN RING RE-INTERVENTION PROCEDURE DUE TO LEAKAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 16623789 ↗InjuryMar 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED THE FOLLOWING INFORMATION FROM PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION AVAILABLE, A MEMO 4D ANNULOPLASTY RING SIZE 34 WHICH WAS IMPLANTED IN THE PATIENT ON (B)(6) 2022, WAS EXPLANTED AND REPLACED WITH ANOTHER SIMILAR DEVICE (4DM-34) ON (B)(6) 2023. NO ALLEGATION OF ANY DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 16539514 ↗InjuryMar 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER RECEIVED THE FOLLOWING INFORMATION FROM PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION AVAILABLE, A MEMO 4D ANNULOPLASTY RING SIZE 34 WHICH WAS IMPLANTED IN THE PATIENT ON (B)(6) 2022, WAS EXPLANTED AND REPLACED WITH ANOTHER SIMILAR DEVICE (4DM-34) ON (B)(6) 2023. NO ALLEGATION OF ANY DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 16539503 ↗InjuryJul 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT'S IMPLANT FORM, ON (B)(6) 2022, MEMO 4D ANNULOPLASTY RING 4DM-34 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14983177 ↗InjuryJul 11, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT'S IMPLANT FORM, ON (B)(6) 2022, MEMO 4D ANNULOPLASTY RING 4DM-34 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14983100 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.