Memo 4DRecalls & reported problems across all models
Corcym Srl · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 0
We found 7 models of Memo 4D by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2021 and Sep 27, 2026 — classified as 27 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Memo 4D problems
Device problems
- Insufficient Device Problem Information19
- Leak/Splash6
- Adverse Event Without Identified Device or Use Problem4
- Detachment of Device or Device Component3
- Difficult to Remove1
Patient problems
- Insufficient Information17
- Mitral Valve Insufficiency/ Regurgitation7
- Endocarditis2
- No Clinical Signs, Symptoms or Conditions2
- Aortic Valve Insufficiency/ Regurgitation1
- Myocardial Infarction1
- Transient Ischemic Attack1
Memo 4D models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Memo 4D 4DM-34RING, ANNULOPLASTY10 reports
- Memo 4D 4DM-30RING, ANNULOPLASTY8 reports
- Memo 4D 4DM-26RING, ANNULOPLASTY3 reports
- Memo 4D 4DM-28RING, ANNULOPLASTY3 reports
- Memo 4D 4DM-32RING, ANNULOPLASTY2 reports
- Memo 4D 4DM-36RING, ANNULOPLASTY2 reports
- Memo 4D 4DM-38RING, ANNULOPLASTY1 report
Recent Memo 4D adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 27, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50909498 ↗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 ↗InjuryJan 16, 2026Insufficient Device Problem Information
THE MANUFACTURER WAS NOTIFIED OF A MEMO4D MITRAL RING, 4DM-30 EXPLANT. REPORTEDLY, THE DEVICE WAS IMPLANTED ON (B)(6) 2025, EXPLANTED ON (B)(6) 2025, AND MITRIS RESILIA WAS IMPLANTED INSTEAD. MANUFACTURER ATTEMPTED TO FOLLOW UP WITH THE SITE BUT WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED, AND THEY DO NOT THINK IT IS REALLY A COMPLAINT.
Patient problems: Insufficient Information
MAUDE report 24099998 ↗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 ↗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 ↗InjuryMay 11, 2025Leak/Splash; Leak/Splash
MANUFACTURER RECEIVED THE INFORMATION FROM DEVICE TRACKING DEPARTMENT. A MEMO 4D ANNULOPLASTY MITRAL REPAIR RING 4DM-30 WAS IMPLANTED IN A PATIENT ON (B)(6) 2021. A MITRAL VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 DUE TO THE MITRAL REGURGITATION. NO OTHER INFORMATION HAS YET BEEN RECEIVED FROM THE SITE.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 21999752 ↗InjuryMay 9, 2025Leak/Splash; Leak/Splash
MANUFACTURER RECEIVED THE INFORMATION FROM DEVICE TRACKING DEPARTMENT. A MEMO 4D ANNULOPLASTY MITRAL REPAIR RING 4DM-30 WAS IMPLANTED IN A PATIENT ON (B)(6) 2021. A MITRAL VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 DUE TO THE MITRAL REGURGITATION. NO OTHER INFORMATION HAS YET BEEN RECEIVED FROM THE SITE.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 21997003 ↗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 ↗InjurySep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH COMPETITOR'S PATIENT TRACKING. BASED ON THE INFORMATION RECEIVED, THE MEMO 4D MITRAL RING 4DM-32 WAS IMPLANTED IN A PATIENT ON (B)(6) 2023. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2023 AND REPLACED WITH MITRIS 25MM. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20160983 ↗InjuryNov 8, 2023Leak/Splash; Leak/Splash
ON (B)(6) 2023, A MEMO4D RING SIZE 30 WAS ATTEMPTED TO BE IMPLANTED. AFTER DE-CLAMP, REGURGITATION DID NOT STOP. AS SUCH, THE DEVICE WAS EXPLANTED ON THE SAME DAY. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: Mitral Valve Insufficiency/ Regurgitation
MAUDE report 18096875 ↗InjuryOct 13, 2023Adverse 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 BECAME AWARE OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. REPORTEDLY, ON (B)(6) 2023, A MEMO 4D ANNULOPLASTY RING SIZE 30 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. BASED ON THE FURTHER INFORMATION RECEIVED, THE RING WAS EXPLANTED DUE TO THE FAILED REPAIR AND WAS REPLACED WITH A VALVE. REPORTEDLY, THERE WAS NO PROBLEM WITH ANNULOPLASTY RING.
Patient problems: Insufficient Information
MAUDE report 17932271 ↗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 ↗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 ↗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 ↗InjuryMar 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY. BASED ON THE INFORMATION RECEIVED, MEMO 4D ANNULOPLASTY RING, SIZE 30 WAS IMPLANTED IN THE PATIENT THROUGH MINI-THORACOTOMY ON (B)(6) 2023.MEAN MITRAL GRADIENT AT THE TIME OF DISCHARGE WAS 7MMHG. REPORTEDLY, MITRAL VALVE ENDOCARDITIS, MODERATE TO SEVERE MI, AND RING DEHISCENCE WAS STARTED ON (B)(6) 2023. BASED ON THE INFORMATION AVAILABLE, MEDICATION WAS ADDED, AND MITRAL VALVE REPLACEMENT WAS PERFORMED ON (B)(6) 2023, AND THE ISSUE WAS RESOLVED. PATIENT HAS A HISTORY OF SYSTEMIC HYPERTENSION. FURTHERMORE, INFECTION DUE TO WOUND HEALING DISTURBANCE WAS REPORTED FOR THE PATIENT ON (B)(6)2023. BASED ON THE PATHOLOGY REPORT RECEIVED FROM THE HOSPITAL, PART OF THE SANDED MATERIAL WAS SUPERIMPOSED IN METHYL ACRYLATE. REPORTEDLY, CONSECUTIVE SECTIONS WERE USED FOR MICROSCOPIC ANALYSIS AND DNA EXTRACTION. THE FLUORESCENCE IN SITU HYBRIDIZATION (FISH) WAS PERFORMED WHICH LED TO DETECTION OF SEVERELY DEGRADED MICROORGANISMS INDIVIDUALLY IN THE TISSUE WITH THE NUCLEIC-SPECIFIC DYE DAPI. REPORTEDLY, NO ACTIVE BACTERIA WAS DETECTED IN THE FISH.
Patient problems: Endocarditis; Mitral Valve Insufficiency/ Regurgitation
MAUDE report 16632775 ↗
Other Corcym Srl products
- CARBOMEDICS SUPRA-ANNULAR (TOP HAT)5 models · 99 reports
- PERCEVAL PLUS4 models · 92 reports
- CARBOMEDICS STANDARD12 models · 83 reports
- MEMO 3D7 models · 54 reports
- CARBOMEDICS ANNULOFLEX6 models · 53 reports
- CARBOMEDICS REDUCED6 models · 39 reports
- CARBOMEDICS OPTIFORM6 models · 37 reports
- MEMO 3D RECHORD6 models · 36 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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