CG FUTURE® 638BL28 (UDI 00613994758774)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00613994758774), received between Dec 1, 2016 and Dec 16, 2025 — classified as 29 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 12 YEARS AND 6 MONTHS POST OF THIS 28MM MITRAL ANNULOPLASTY BAND , A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR (AV) NODE ABLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23814745 ↗
• InjurySep 13, 2024Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 11 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Stenosis

  MAUDE report 20212522 ↗
• InjuryMar 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 4 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC 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 13636881 ↗
• InjuryDec 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 6 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 33MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12908751 ↗
• InjuryJun 30, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12096350 ↗
• InjuryJun 14, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANTATION OF THIS ANNULOPLASTY BAND, THE SURGEON THOUGHT THAT THERE WAS "POOR FORMING". AS A RESULT THE BAND WAS NOT USED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11991034 ↗
• InjuryFeb 23, 2021Adverse 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 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC 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 11365582 ↗
• InjuryFeb 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11267717 ↗
• InjuryFeb 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 1 MONTH POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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 9671139 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. IT WAS REPLACED WITH A NON MEDTRONIC DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9255538 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 10 MONTHS POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE DUE SEVERE REGURGITATION. DURING THE EXPLANT PROCEDURE, THE SURGEON NOTED THAT THE RING WAS INTACT. THE PATIENT'S NATIVE POSTERIOR LEAFLET HAD BEEN REPAIRED PREVIOUSLY WITH A SUTURE, AND NOW WAS RETRACTED, WHICH THE SURGEON STATED WAS THE CAUSE OF THE SEVERE REGURGITATION, NOT FAILURE OF THE ANNULOPLASTY PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8620360 ↗
• InjuryOct 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT DAYS POST IMPLANT OF THIS ANNULOPLASTY RING AND ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 7966288 ↗
• InjuryOct 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SIX MONTHS FOLLOWING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY RING. IMMEDIATELY FOLLOWING THE IMPLANT OF THE RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASONS FOR EXPLANTING THE RING AND THE ORIGINAL BAND ARE UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7943185 ↗
• InjuryJul 13, 2018Pacing Inadequately; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 19 DAYS POST IMPLANT OF THIS ANNULOPLASTY BAND, A NON-MEDTRONIC PERMANENT PACEMAKER WAS IMPLANTED DUE TO SINUS BRADYCARDIA AND ATRIAL FIBRILLATION. THE PATIENT'S HEART RATE WAS REPORTED AS 35 BEATS PER MINUTE DURING THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Bradycardia

  MAUDE report 7686086 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THIS 28MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE RING WAS REPLACED WITH A 27MM BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 7679590 ↗
• InjuryJun 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS AND ONE MONTH POST IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Adhesion(s); Mitral Regurgitation; No Information; Scarring

  MAUDE report 7640948 ↗
• InjuryApr 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND WAS IMPLANTED AND EXPLANTED. THE REASON FOR EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7438646 ↗
• InjuryMar 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING AN IMPLANT, THIS MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED. THE REASON FOR EXPLANT WAS REPORTED AS RECURRENT REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7387234 ↗
• InjuryMar 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 28MM MITRAL ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE AND REPLACED WITH A VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7351264 ↗
• InjuryFeb 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY BAND THE PHYSICIAN REPORTED THE NATIVE MITRAL VALVE WAS VERY DIFFICULT TO EXPOSE AND PLACE SUTURES IN. FOLLOWING IMPLANT, TESTING OF THE VALVE REVEALED NO INSUFFICIENCY. AS THE CHEST WAS BEING CLOSED THE VALVE HAD SEVERE INSUFFICIENCY. THE PATIENT WAS PLACED BACK ON BYPASS AND NO SPECIFIC CAUSE FOR THE INSUFFICIENCY WAS FOUND HOWEVER, THE ANTERIOR LEAFLET NOW APPEARED TO BE PROTRUDING OVER THE ANNULUS. THE ANNULOPLASTY BAND WAS REMOVED AND REPLACED WITH A COMPLETE 28MM NON-MEDTRONIC ANNULOPLASTY RING. THE PHYSICIAN DECIDED THAT A COMPLETE RING MAY HELP THE INSUFFICIENCY. FOLLOWING THE IMPLANT OF THE NON-MEDTRONIC RING, INSUFFICIENCY REMAINED AND THE PHYSICIAN REPLACED THE RING WITH A 27MM NON-MEDTRONIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Insufficiency

  MAUDE report 7252895 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR 10 MONTHS POST IMPLANT OF THIS 28 MM MITRAL ANNULOPLASTY BAND WAS EXPLANTED AND REPLACED WITH A 29 MM MITRAL MECHANICAL VALVE FOR UNKNOWN REASONS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 7104618 ↗
• InjuryNov 20, 2017Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT THIS 28 MM MITRAL BIOPROSTHETIC BAND WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. POST IMPLANT OF THE 28 MM, AFTER TIED AND SUTURED INTO PLACE, THE PHYSICIAN NOTED THAT THE LEAFLETS COAPTED WELL AND THERE WAS ESSENTIALLY NO REGURGITATION. A POST IMPLANTED TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS DONE WHICH SHOWED VISUALLY THE VALVE LOOKED COMPLETELY NORMAL, ONCE A DOPPLER WAS PLACED ON THE VALVE, IT WAS EVIDENT THAT ALTHOUGH IMPROVED, THERE WAS SIGNIFICANT MITRAL REGURGITATION AND THE ANTERIOR LEAFLET APPEARED TO BE LEAKING, BUT THE POSTERIOR LEAFLET WAS NOT PROLAPSING. THE PHYSICIAN DECIDED THAT THERE WAS TOO MUCH REGURGITATION TO LEAVE THE BAND IN PLACE, SO THE PATIENT WAS PLACED BACK ON BYPASS. THE 28 MM BAND WAS REMOVED AND SUCCESSFULLY REPLACED WITH A 29 MM BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 7045113 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM THAT DURING IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 31 MM BIOPROSTHETIC VALVE. THE PHYSICIAN DETERMINED THAT BECAUSE OF PATIENT ANATOMY, THE RING WOULD NOT PROVIDE THE REPAIR THE PATIENT NEEDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7022305 ↗
• InjuryNov 10, 2017Adverse 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 THIS 28MM MITRAL ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. THE DEVICE WAS REPLACED WITH A 26MM ANNULOPLASTY RING FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 7017714 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION FROM THE HEALTH CARE FACILITY (HCF) VIA OPERATIVE REPORT, THAT THE PATIENT RECEIVED A MITRAL ANNULOPLASTY BAND, INTRAOPERATIVE TESTING SHOWED A PERSISTENT CENTRAL REGURGITATION DUE TO NATIVE VALVE LEAFLET RESTRICTION AND THICKENING. THE PHYSICIAN MADE THE DECISION TO REMOVE THE BAND, AND REPLACED IT WITH A BIOPROSTHETIC MITRAL VALVE. POST OPERATIVE SHOWED GOOD VALVE FUNCTION WITH NO REGURGITATION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6853909 ↗