CG FUTURE® 638RL28 (UDI 00613994521057)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994521057), received between Oct 8, 2018 and Sep 11, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Incomplete Coaptation” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED. THE REASON FOR THE ICD IMPLANT WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20194174 ↗
• InjuryJun 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 4 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, THE DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis; No Information

  MAUDE report 8705665 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 24 DAYS AFTER THE IMPLANT OF THIS MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO SICK SINUS SYNDROME, TACHYCARDIA-BRADYCARDIA SYNDROME AND ATRIAL FIBRILLATION (AFIB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Non specific EKG/ECG Changes

  MAUDE report 8014385 ↗
• InjuryOct 8, 2018Incomplete Coaptation; Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS AND ELEVEN MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE INDICATION FOR REPLACEMENT WAS SEVERE REGURGITATION AND MODERATE STENOSIS. EXAMINATION OF THE NATIVE MITRAL VALVE REVEALED THICKENED ANTERIOR AND POSTERIOR LEAFLETS. THE POSTERIOR LEAFLET APPEARED RETRACTED, AND THE SURGEON FELT THIS WAS CONTRIBUTING TO THE INSUFFICIENCY. DURING THE REPLACEMENT PROCEDURE, A TRAPEZOID PORTION OF THE ANTERIOR LEAFLET WAS RESECTED, AND THE POSTERIOR LEAFLET WAS RETAINED. ADDITIONALLY, THE NATIVE TRICUSPID VALVE WAS REPAIRED WITH AN ANNULOPLASTY RING. POST-OPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DEMONSTRATED MILD MITRAL INSUFFICIENCY AND TRIVIAL TRICUSPID INSUFFICIENCY. NO ADDITIONAL INTERVENTIONS TOOK PLACE, AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; Mitral Valve Stenosis

  MAUDE report 7943244 ↗