MEMO 3D SMD38Recalls & 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 08022057013163), received between Sep 25, 2017 and Sep 25, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- Heart Failure1
- Mitral Regurgitation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2017Patient-Device Incompatibility; Patient-Device Incompatibility
A MEMO 3D SIZE 38 WAS IMPLANTED ON (B)(6) 2017. ON (B)(6) 2017, DUE TO A SEVERE, PERSISTENT MR, THE PATIENT WAS RE-OPERATED. THE SURGEON REMOVED THE RING, PERFORMED A LEAFLET RECONSTRUCTION, AND IMPLANTED A NEW MEMO 3D SIZE 38. THE SURGERY WAS MINIMALLY INVASIVE. THE PATIENT REQUIRED ECMO TREATMENT DUE TO HEART FAILURE. ECMO WAS DISCONTINUED ON (B)(6) 2017, AND THE PATIENT IS NOW DOING WELL. THE MANUFACTURER WAS NOTIFIED OF THIS EVENT ON 29-AUG-2017.
Patient problems: Heart Failure; Mitral Regurgitation
MAUDE report 6891241 ↗
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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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