MEMO 3D SMD34Recalls & reported problems
Corcym Srl · Class 2 · Implant
- 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 08022057013149), received between Mar 20, 2019 and May 3, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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
- Insufficient Device Problem Information3
Patient problems
- Insufficient Information2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryMar 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2019, A MEMO 3D SMD34 ICV0971 IMPLANT ATTEMPT OCCURRED. HOWEVER, IT IS REPORTED THAT THE DEVICE WAS IMPLANTED AND EXPLANTED DURING THE PROCEDURE. DESPITE THE ATTEMPTED FOLLOW UP, NO FURTHER INFORMATION ON THIS EVENT HAS BEEN RECEIVED.
Patient problems: No Information
MAUDE report 8438936 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.