MEMO 3D RECHORD MRCS28Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08022057015075), received between Apr 7, 2017 and Oct 16, 2019 — classified as 9 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A PATIENT WAS INTENDED TO RECEIVE A MEMO3D-RECHORD #28 ON (B)(6) 2019. THE MANUFACTURER WAS NOTIFIED THE DEVICE WAS IMPLANT/ED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9198587 ↗
• InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A PATIENT WAS INTENDED TO RECEIVE A MEMO3D-RECHORD #28 ON (B)(6) 2019. THE MANUFACTURER WAS NOTIFIED THE DEVICE WAS IMPLANT/ED AND EXPLANTED ON THE SAME DAY. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Information

  MAUDE report 9198529 ↗
• InjuryOct 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019, A MITRAL VALVE REPAIR WITH A MEMO 3D-RECHORD WAS PERFORMED. THE IMPLANT OF THE RING WAS PERFORMED USING THE HORIZONTALLY MATTRESSED 2-0 TICRON CIRCUMFERENTIALLY. OTHER CONCOMITANT PROCEDURES WERE ALSO PERFORMED (CORONARY ARTERY BYPASS GRAFTING X 1, INTRAOPERATIVE CORONARY ANGIOGRAPHY OF THE LIMA-LAD ANASTOMOSIS; INSERTION OF RIGHT COMMON FEMORAL ARTERIAL INTRA-AORTIC BALLOON PUMP). ON (B)(6) 2019, THE PATIENT WAS ADMITTED ON (B)(6) 2019 TO THE EMERGENCY DEPARTMENT FOR SHORTNESS OF BREATH. THE DIAGNOSIS WAS OF ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION WITH RVR, ELEVATED SERUM CREATININE, PNEUMONIA DUE TO ORGANISM. ON (B)(6) 2019, RING DEHISCENCE WAS DETECTED THROUGH THE ECHO. THE PATIENT IS BEING MONITORED BUT THE RING HAS NOT BEEN EXPLANTED YET. THE CURRENT DIAGNOSIS IS OF DILATED CARDIOMYOPATHY, ESSENTIAL HYPERTENSION, AND PAROXYSMAL ATRIAL FIBRILLATION. BASED ON THE PHYSICIAN'S ASSESSMENT, A POTENTIAL CONTRIBUTORY FACTOR TO THE REPORTED DEHISCENCE COULD BE IDENTIFIED IN THE STITCHING AREA, WHICH WAS REPORTEDLY VERY THIN.

  Patient problems: Dyspnea

  MAUDE report 9142693 ↗
• InjuryOct 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019, A MITRAL VALVE REPAIR WITH A MEMO 3D-RECHORD WAS PERFORMED. THE IMPLANT OF THE RING WAS PERFORMED USING THE HORIZONTALLY MATTRESSED 2-0 TICRON CIRCUMFERENTIALLY. OTHER CONCOMITANT PROCEDURES WERE ALSO PERFORMED (CORONARY ARTERY BYPASS GRAFTING X 1, INTRAOPERATIVE CORONARY ANGIOGRAPHY OF THE LIMA-LAD ANASTOMOSIS; INSERTION OF RIGHT COMMON FEMORAL ARTERIAL INTRA-AORTIC BALLOON PUMP). ON (B)(6) 2019, THE PATIENT WAS ADMITTED ON (B)(6) 2019 TO THE EMERGENCY DEPARTMENT FOR SHORTNESS OF BREATH. THE DIAGNOSIS WAS OF ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION WITH RVR, ELEVATED SERUM CREATININE, PNEUMONIA DUE TO ORGANISM. ON (B)(6) 2019, RING DEHISCENCE WAS DETECTED THROUGH THE ECHO. THE PATIENT IS BEING MONITORED BUT THE RING HAS NOT BEEN EXPLANTED YET. THE CURRENT DIAGNOSIS IS OF DILATED CARDIOMYOPATHY, ESSENTIAL HYPERTENSION, AND PAROXYSMAL ATRIAL FIBRILLATION. BASED ON THE PHYSICIAN'S ASSESSMENT, A POTENTIAL CONTRIBUTORY FACTOR TO THE REPORTED DEHISCENCE COULD BE IDENTIFIED IN THE STITCHING AREA, WHICH WAS REPORTEDLY VERY THIN.

  Patient problems: Dyspnea

  MAUDE report 9142686 ↗
• InjurySep 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019, A MITRAL VALVE REPAIR WITH A MEMO 3D-RECHORD WAS PERFORMED. THE IMPLANT OF THE RING WAS PERFORMED USING THE HORIZONTALLY MATTRESSED 2-0 TICRON CIRCUMFERENTIALLY. DURING THE SAME SURGERY, THREE OTHER CONCOMITANT PROCEDURES OCCURRED: A TRICUSPID VALVE REPLACEMENT WITH A 33MM EDWARDS BIOPROSTHESIS, AND A BI-ATRIAL MAZE PROCEDURE, WITH ABLATION OF BOTH THE ANTERIOR AND POSTERIOR MITRAL TRIGONES; A LIGATION OF THE LEFT ATRIAL APPENDAGE. AN INITIAL NORMAL POSTOPERATIVE COURSE WAS REPORTED. THE PATIENT WAS SEEN IN BY A CARDIOLOGIST FOR FOLLOW UP VISIT ON (B)(6) 2019. LOW K LEVEL WAS NOTICED. THE PATIENT WAS CONSEQUENTLY SENT TO ED ON (B)(6) 2019 FOR FURTHER WORKUP, AND POSTERIOR RING DEHISCENCE WAS NOTICED ON THE ECHO. THE DIAGNOSIS WAS: HYPOKALEMIA, ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, UNSPECIFIED HEART FAILURE TYPE. CURRENTLY, THE PATIENT PRESENTS SEVERE MITRAL REGURGITATION AND IS VERY SYMPTOMATIC WITH DYSPNEA, FATIGUE, ORTHOPNEA, AND NOCTURNAL DESATURATION. THE PATIENT WAS EVALUATED FOR A MITRACLIP BUT WAS FOUND NOT TO BE A CANDIDATE DUE TO INSUFFICIENT ACCESS TO LEAFLETS. A RE-DO STERNOTOMY AND BIOPROSTHETIC MVR IS PLANNED, BUT NO RE-INTERVENTION HAS BEEN PERFOR

  Patient problems: Dyspnea; Fatigue; Mitral Insufficiency

  MAUDE report 9137684 ↗
• InjurySep 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019, A MITRAL VALVE REPAIR WITH A MEMO 3D-RECHORD WAS PERFORMED. THE IMPLANT OF THE RING WAS PERFORMED USING THE HORIZONTALLY MATTRESSED 2-0 TICRON CIRCUMFERENTIALLY. DURING THE SAME SURGERY, THREE OTHER CONCOMITANT PROCEDURES OCCURRED: A TRICUSPID VALVE REPLACEMENT WITH A 33MM EDWARDS BIOPROSTHESIS, AND A BI-ATRIAL MAZE PROCEDURE, WITH ABLATION OF BOTH THE ANTERIOR AND POSTERIOR MITRAL TRIGONES; A LIGATION OF THE LEFT ATRIAL APPENDAGE. AN INITIAL NORMAL POSTOPERATIVE COURSE WAS REPORTED. THE PATIENT WAS SEEN IN BY A CARDIOLOGIST FOR FOLLOW UP VISIT ON (B)(6) 2019. LOW K LEVEL WAS NOTICED. THE PATIENT WAS CONSEQUENTLY SENT TO ED ON (B)(6) 2019 FOR FURTHER WORKUP, AND POSTERIOR RING DEHISCENCE WAS NOTICED ON THE ECHO. THE DIAGNOSIS WAS: HYPOKALEMIA, ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, UNSPECIFIED HEART FAILURE TYPE. CURRENTLY, THE PATIENT PRESENTS SEVERE MITRAL REGURGITATION AND IS VERY SYMPTOMATIC WITH DYSPNEA, FATIGUE, ORTHOPNEA, AND NOCTURNAL DESATURATION. THE PATIENT WAS EVALUATED FOR A MITRACLIP BUT WAS FOUND NOT TO BE A CANDIDATE DUE TO INSUFFICIENT ACCESS TO LEAFLETS. A RE-DO STERNOTOMY AND BIOPROSTHETIC MVR IS PLANNED, BUT NO RE-INTERVENTION HAS BEEN PERFOR

  Patient problems: Dyspnea; Fatigue; Mitral Insufficiency

  MAUDE report 9137666 ↗
• InjuryFeb 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MEMO 3D RECHORD, SIZE 28, WAS IMPLANTED AND EXPLANTED INTRA-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 8368693 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018 A MEMO 3D, MRCS28 MECHANICAL MITRAL VALVE REPAIR RING WAS INVOLVED IN A PROCEDURE. THE MANUFACTURER WAS NOTIFIED THAT THE DEVICE WAS REMOVED AND NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8224810 ↗
• InjuryApr 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH PATIENT TRACKING ON (B)(6) 2017 THAT THIS DEVICE WAS IMPLANTED AND THEN EXPLANTED ON (B)(6) 2017. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THE REASON FOR EXPLANT.

  Patient problems: No Information

  MAUDE report 6472127 ↗