CG FUTURE™ 638RL38Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169793576), received between Dec 9, 2018 and Jul 15, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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

Recent adverse event reports

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

• InjuryJul 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED INCREASING AMOUNTS OF LEFT PLEURAL EFFUSION. THE PATIENT WAS HOSPITALIZED AND MEDICATION WAS ADMINISTERED. THE PATIENT ALSO HAD SYMPTOMS OF SHORTNESS OF BREATH. IT WAS STATED THAT THE SYMPTOMS IMPROVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Pleural Effusion

  MAUDE report 19742779 ↗
• InjuryMay 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT PERICARDIAL EFFUSION WAS OBSERVED ON A ECHOCARDIOGRAM. IT WAS STATED THAT ECHOCARDIOGRAPHY SHOWED A CIRCULAR PERICARDIAL EFFUSION MEASURING 15 MM LATERAL TO THE RIGHT VENTRICLE (RV) AND EXTENDING TO 23 MM LATERAL TO THE LEFT VENTRICLE. ON THE SAME DAY, AN ATTEMPTED PERICARDIAL PUNCTURE WAS PERFORMED AND WAS UNSUCCESSFUL. IT WAS REPORTED THAT PERICARDIAL DRAINAGE AND FENESTRATION WAS SUBSEQUENTLY PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pericardial Effusion

  MAUDE report 19268295 ↗
• InjuryApr 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT PLEURAL EFFUSION WAS DUE TO SURGICAL INTERVENTION ON THE HEART CAVITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pleural Effusion

  MAUDE report 19171334 ↗
• InjuryJan 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT PERICARDIAL EFFUSION WAS POSSIBLY RELATED TO THE PROCEDURE OR TO THE DEVICE IMPLANT DUE TO THE SURGICAL INTERVENTION ON THE HEART CAVITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Tamponade; Pericardial Effusion

  MAUDE report 18462406 ↗
• InjuryNov 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT MANUFACTURERS DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18187542 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A N ON-MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 13757185 ↗
• InjuryNov 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 42 DAYS POST IMPLANT OF THIS 38 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29 MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 10774737 ↗
• InjuryJan 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8236368 ↗
• InjuryDec 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8145252 ↗