MEMO 3DRecalls & 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
- 54
- Deaths reported
- 1
- Injuries reported
- 53
- Recalls
- 0
We found 7 models of MEMO 3D by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2016 and Sep 6, 2024 — classified as 1 death, 53 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (47 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 3D problems
Device problems
- Insufficient Device Problem Information47
- Adverse Event Without Identified Device or Use Problem22
- Patient-Device Incompatibility4
Patient problems
- No Information35
- Insufficient Information13
- No Known Impact Or Consequence To Patient10
- Mitral Regurgitation5
- Heart Failure1
- Heart Failure/Congestive Heart Failure1
- Myocardial Infarction1
MEMO 3D models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MEMO 3D SMD30RING, ANNULOPLASTY17 reports
- MEMO 3D SMD32RING, ANNULOPLASTY1 death13 reports
- MEMO 3D SMD28RING, ANNULOPLASTY12 reports
- MEMO 3D SMD26RING, ANNULOPLASTY7 reports
- MEMO 3D SMD34RING, ANNULOPLASTY3 reports
- MEMO 3D SMD36RING, ANNULOPLASTY1 report
- MEMO 3D SMD38RING, ANNULOPLASTY1 report
Recent MEMO 3D adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
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 3D RING ICV0970 WAS IMPLANTED IN A PATIENT ON (B)(6) 2023. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2023 AND REPLACED WITH PHYSIO II 30MM. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20161219 ↗InjuryMay 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURE WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A PATIENT RECEIVED A MEMO 3D SEMIRIGID ANNULOPLASTY RING, SMD30 IN MITRAL POSITION ON (B)(6) 2022. REPORTEDLY, THE RING WAS EVENTUALLY REPLACED WITH OPTIFORM PROSTHETIC MITRAL HEART VALVE SIZE 29MM ON (B)(6) 2023. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE.
Patient problems: Insufficient Information
MAUDE report 16970116 ↗InjuryMay 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURE WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION RECEIVED, A PATIENT RECEIVED A MEMO 3D SEMIRIGID ANNULOPLASTY RING, SMD30 IN MITRAL POSITION ON (B)(6) 2022. REPORTEDLY, THE RING WAS EVENTUALLY REPLACED WITH OPTIFORM PROSTHETIC MITRAL HEART VALVE SIZE 29MM ON (B)(6) 2023. NO ALLEGATION OF DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT HAS BEEN RECEIVED FROM THE SITE.
Patient problems: Insufficient Information
MAUDE report 16963359 ↗DeathApr 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED THROUGH MANTRA STUDY THAT A PATIENT IMPLANTED WITH A MEMO 3D SIZE 32 MITRAL ANNULOPLASTY RING PASSED AWAY ON (B)(6) 2022. THE EVENT WAS A SUDDEN DEATH OCCURRING DURING THE NIGHT WHILE THE PATIENT WAS SLEEPING. THE RING HAD BEEN IMPLANTED ON (B)(6) 2021 THROUGH MEDIAN STERNOTOMY AND CONCOMITANT CABG HAD BEEN PERFORMED IN THE SAME SURGERY PRIOR TO RING IMPLANTATION. THE PATIENT WAS IN PARTICULARLY COMPLEX HEALTH CONDITIONS AND SUFFERED FROM BRONCHOPATHY WITH SLEEP APNEA. HE HAD A PREVIOUS HISTORY OF CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION (<= 90 DAYS AT THE TIME OF SURGERY), ISCHEMIC HEART FAILURE, DIABETES MELLITUS TYPE II, DYSLIPIDEMIA. HE ALSO HAD A TOBACCO HISTORY AND WAS NYHA CLASS III.
Patient problems: Heart Failure/Congestive Heart Failure; Myocardial Infarction
MAUDE report 16782945 ↗InjuryJun 19, 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 3D SEMIRIGID ANNULOPLASTY RING SMD26 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 14740345 ↗InjuryJun 19, 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 3D SEMIRIGID ANNULOPLASTY RING SMD26 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 14740344 ↗InjuryMay 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION ON PATIENT'S IMPLANT FORM, MEMO 3D SIZE 34 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT WAS RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14270284 ↗InjuryMay 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH PATIENT TRACKING DATABASE. BASED ON THE INFORMATION ON PATIENT'S IMPLANT FORM, MEMO 3D SIZE 34 WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY ON (B)(6) 2022. NO ALLEGATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY ON THE PATIENT WAS RECEIVED FROM THE HOSPITAL REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 14270283 ↗InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D SEMIRIGID ANNULOPLASTY RING SMD26 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2021. ANOTHER SIMILAR DEVICE SMD26 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11898619 ↗InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D SEMIRIGID ANNULOPLASTY RING SMD28 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2021. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11898182 ↗InjuryMay 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryApr 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT.BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D #30 DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. ANOTHER MEMO 3D #30 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION OR PATIENT OUTCOME WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11605937 ↗InjuryApr 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURE WAS INFORMED OF THE EVENT THROUGH THE PATIENT TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D #30 DEVICE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY ON (B)(6) 2021. ANOTHER MEMO 3D #30 WAS FINALLY IMPLANTED. NO FURTHER INFORMATION ABOUT ANY DEVICE MALFUNCTION OR PATIENT OUTCOME WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 11605936 ↗InjuryNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED ON THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED ON THE PATIENT IMPLANT FORM, A MEMO 3D SMD32 WAS IMPLANTED AND EXPLANTED ON (B)(6) 2020. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO INDICATION OF A DEVICE MALFUNCTION NOR SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.
Patient problems: No Information
MAUDE report 10787766 ↗
Other Corcym Srl products
- CARBOMEDICS SUPRA-ANNULAR (TOP HAT)5 models · 99 reports
- PERCEVAL PLUS4 models · 92 reports
- CARBOMEDICS STANDARD12 models · 83 reports
- CARBOMEDICS ANNULOFLEX6 models · 53 reports
- CARBOMEDICS REDUCED6 models · 39 reports
- CARBOMEDICS OPTIFORM6 models · 37 reports
- MEMO 3D RECHORD6 models · 36 reports
- Memo 4D7 models · 29 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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