Memo 4D 4DM-28Recalls & reported problems
Corcym Srl · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08022057015426), received between Oct 1, 2021 and May 31, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT REGISTRATION FORM (PRF), A MEMO4D ANNULOPLASTY RING SIZE 28 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS YET BEEN RECEIVED FROM THE SITE.
Patient problems: Insufficient Information
MAUDE report 17035188 ↗InjuryOct 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER WAS NOTIFIED OF A CASE OF MEMO 4D (4DM-28 ) RING DEHISCENCE AFTER 1 YEAR OF IMPLANT (DOI: (B)(6) 2020, AND DOE: (B)(6) 2021). THE PATIENT WAS RE-OPERATED WITH GOOD RESULTS. BASED ON THE PRELIMINARY INFORMATION RECEIVED, THE EVENT APPEARS TO BE RELATED TO A DETACHMENT OF THE SUTURES AND NOT TO A DETACHMENT OF THE FABRIC OF THE RING. THE PATIENT WAS ALREADY DISCHARGED FROM THE HOSPITAL. THE DEVICE IS UNAVAILABLE FOR RETURN AS IT WAS ALREADY DISCARDED BY THE SITE. THE DEVICE WAS REPLACED WITH AN EDWARDS PHISIO II SIZE 26.
Patient problems: Insufficient Information
MAUDE report 12566061 ↗InjuryOct 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER WAS NOTIFIED OF A CASE OF MEMO 4D (4DM-28 ) RING DEHISCENCE AFTER 1 YEAR OF IMPLANT (DOI: (B)(6) 2020, AND DOE: (B)(6) 2021). THE PATIENT WAS RE-OPERATED WITH GOOD RESULTS. BASED ON THE PRELIMINARY INFORMATION RECEIVED, THE EVENT APPEARS TO BE RELATED TO A DETACHMENT OF THE SUTURES AND NOT TO A DETACHMENT OF THE FABRIC OF THE RING. THE PATIENT WAS ALREADY DISCHARGED FROM THE HOSPITAL. THE DEVICE IS UNAVAILABLE FOR RETURN AS IT WAS ALREADY DISCARDED BY THE SITE. THE DEVICE WAS REPLACED WITH AN EDWARDS PHISIO II SIZE 26.
Patient problems: Insufficient Information
MAUDE report 12566059 ↗
Other RING, ANNULOPLASTY devices
- CG FUTURE™ 638BL32Medtronic, Inc. · RING, ANNULOPLASTY1 death71 reports
- PROFILE 3D® 680R28Medtronic, Inc. · RING, ANNULOPLASTY1 death67 reports
- CG FUTURE™ 638BL30Medtronic, Inc. · RING, ANNULOPLASTY1 death65 reports
- CG FUTURE™ 638RL32Medtronic, Inc. · RING, ANNULOPLASTY59 reports
- Tri-Ad™ 900SFC228Medtronic, Inc. · RING, ANNULOPLASTY4 deaths56 reports
- CG FUTURE™ 638BL34Medtronic, Inc. · RING, ANNULOPLASTY51 reports
- Contour 3D® 690R30Medtronic, Inc. · RING, ANNULOPLASTY1 death50 reports
- CG FUTURE™ 638RL30Medtronic, Inc. · RING, ANNULOPLASTY1 death47 reports
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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