Duran AnCore® 620BG31Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00613994759122), received between Nov 30, 2016 and Mar 31, 2025 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 4 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND R EPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21732042 ↗
• InjuryOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 28MM MITRAL ANNULOPLASTY RING. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20429183 ↗
• InjuryMar 28, 2024Material Separation; Insufficient Device Problem Information; Intravalvular regurgitation; Material Separation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE TRICUSPID REGURGITATION WITH PARTIAL BAND DEH ISCENCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 19000805 ↗
• InjuryAug 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR REPLACEMENT WAS BACTERIAL ENDOCARDITIS. IT WAS STATED THAT BLOOD CULTURES GREW STREPTOCOCCUS ANGINOSUS. IT WAS REPORTED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED THE PRESENCE OF VEGETATION ON THE ATRIAL ASPECT OF THE MITRAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 17436530 ↗
• InjuryJun 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS, "IT NEEDED TO BE REPLACED WITH NO SPECIFIC ETIOLOGY". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17105595 ↗
• InjuryNov 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 31MM ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. 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 10868890 ↗
• InjurySep 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS ANNULOPLASTY BAND, THERE WAS STILL MODERATELY SEVERE RESIDUAL MITRAL INSUFFICIENCY. THE BAND WAS REMOVED AND REPLACED WITH A 31MM NON-MEDTRONIC BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Insufficiency

  MAUDE report 8965553 ↗
• InjuryAug 1, 2019Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Mitral Regurgitation; No Information

  MAUDE report 8852607 ↗
• InjuryOct 19, 2018Incomplete Coaptation; Insufficient Device Problem Information; Incomplete Coaptation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FIVE MONTHS AND TWENTY-SEVEN DAYS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A 25MM BIOPROSTHETIC VALVE. THE REASON FOR EXPLANT WAS REPORTED AS SEVERE MITRAL REGURGITATION, WITH RETRACTION OF THE ANTERIOR LEAFLET. A GAP WAS NOTED BETWEEN THE ANTERIOR AND POSTERIOR LEAFLETS, ALONG WITH THE A3 AND P3. DESPITE MULTIPLE ATTEMPTS TO WEAN FROM BYPASS, THE RIGHT VENTRICLE (RV) WAS NOT FUNCTIONING AS EXPECTED. THE SURGEON PLACED THE PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 7985020 ↗
• InjuryJul 18, 2018Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY BAND, THE BAND 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 Code Available; No Information

  MAUDE report 7699166 ↗
• InjuryMar 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 31 MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH 35 MM MITRAL ANNULOPLASTY BAND. THE PHYSICIAN STATED THAT THERE WAS NOTHING WRONG WITH THE DEVICE, BUT THAT THE PATIENT HAD (SAM) SYSTOLIC ANTERIOR MOTION WHICH WAS BETTER MANAGED WITH THE LARGER BAND. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7341204 ↗
• InjuryMar 8, 2018Adverse 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 3 MONTHS POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, THE BAND WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL 32MM ANNULOPLASTY BAND. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7323561 ↗
• InjuryFeb 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS MITRAL ANNULOPLASTY BAND, THE BAND 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 7252803 ↗
• InjuryDec 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING, THE PATIENT PRESENTED WITH PALPITATIONS AND ATRIAL FIBRILLATION (AFIB). THE ECHOCARDIOGRAM SHOWED SEVERE MITRAL REGURGITATION. MEDICAL TREATMENT WAS ADMINISTERED AND SUBSEQUENTLY, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Mitral Regurgitation

  MAUDE report 7147817 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE WEEK POST IMPLANT OF THIS 31MM MITRAL ANNULOPLASTY BAND, IT WAS EXPLANTED AND REPLACED WITH A 34MM MITRAL ANNULOPLASTY BAND FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ischemic Heart Disease; No Information

  MAUDE report 7075736 ↗
• InjuryJul 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS ANNULOPLASTY BAND WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. THE DEVICE WAS REPLACED WITH A BIOPROSTHETIC VALVE FOR UNKNOWN REASONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6699997 ↗
• InjuryJun 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOUR YEARS, FIVE MONTHS POST IMPLANT OF THIS ANNULOPLASTY BAND IN THE MITRAL POSITION, THIS DEVICE WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Angina; Congestive Heart Failure; Mitral Insufficiency; No Information

  MAUDE report 6674083 ↗
• InjuryNov 30, 2016Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS 31MM ANNULOPLASTY BAND, THIS BAND WAS EXPLANTED AND REPLACED WITH A 29MM BAND. NO FAILURE MODE AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 6137362 ↗