PROFILE 3D® 680R30Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00613994759238), received between Mar 6, 2017 and Nov 14, 2025 — classified as 1 death, 38 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (28 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 30MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN NEW HEART RING IN THE MITRAL POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23554313 ↗
• InjuryOct 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AN UNSUCCESSFUL REPAIR. IT WAS REPORTED THAT THE ANNULOPLASTY PRODUCT MALFUNCTIONED AND WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23427597 ↗
• InjuryAug 26, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 6 MONTHS POST IMPLANT OF THIS 30MM PROFILE 3D HEART RING, IT 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: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22894097 ↗
• InjuryJun 16, 2025Calcified; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Calcified; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS SEVERE MITRAL STENOSIS AND TRACE MITRAL REGURGITATION. IT WAS ALSO REPORTED THAT THE MITRAL LEAFLETS WERE SEVERELY THICKENED AND CALCIFIED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 22209899 ↗
• InjuryFeb 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THESE PROFILE 3D AND CONTOUR 3D ANNULOPLASTY RINGS, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21363123 ↗
• MalfunctionNov 14, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 5 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT A FOLLOW-UP ECHOCARDIOGRAM (ECHO) DISCOVERED MODERATE MITRAL REGURGITATION. IT WAS ALSO STATED THAT THE PATIENT WAS EXPERIENCING DYSPNEA. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20688153 ↗
• InjuryOct 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING AND 30MM MITRAL ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK/COMPLETE HEART BLOCK AND ATRIAL ARRHYTHMIAS INDICATED TO BE ATRIAL TACHYCARDIA, ATRIAL FIBRILLATION (AFIB) AND ATRIAL FLUTTER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Tachycardia

  MAUDE report 20449258 ↗
• DeathOct 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT REPRESENTATIVE THAT ON THE SAME DAY AS THE IMPLANT DATE OF THIS 30MM ANNULOPLASTY RING, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE 30MM ANNULOPLASTY RING COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 20406880 ↗
• InjurySep 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM MITRAL MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20147651 ↗
• InjuryMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM ANNULOPLASTY RING, 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

  MAUDE report 19352834 ↗
• InjuryMar 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT HAD RIGHT BUNDLE BRANCH BLOCK (RBBB). ANTICOAGULANT, ASPIRIN AND ANTIPLATELET WERE GIVEN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18908770 ↗
• InjuryMar 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING AND THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT DEVELOPED THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK. IT WAS ALSO REPORTED THAT TEMPORARY PACING WAS PROVIDED, THE AV BLOCK WAS TRANSIENT AND NO PERMANENT PACEMAKER WAS NEEDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18902451 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 WEEK POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 18428717 ↗
• InjuryDec 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, THIRD DEGREE ATRIO-VENTRICULAR BLOCK (AVB) WAS OBSERVED ON A ELECTROCARDIOGRAM (ECG). IT WAS STATED THAT THIS WAS POSSIBLY DUE TO PERIOPERATIVE DAMAGE OF THE CONDUCTION SYSTEM. 1 WEEK LATER, A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18396894 ↗
• InjuryMay 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE 30MM MITRAL ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC BIO PROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16937475 ↗
• InjuryMay 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16885067 ↗
• InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16470723 ↗
• InjuryOct 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A N ON-MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT'S NATIVE MITRAL VALVE REQUIRED REPLACEMENT DUE TO ENDOCARDITIS AND A REPAIR WAS ATTEMPTED BUT ULTIMATELY REPLACED WITH A NON-MEDTRONIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15611496 ↗
• InjuryFeb 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 8 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, 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 13415372 ↗
• InjuryJan 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13315486 ↗
• InjuryOct 18, 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 9 YEARS AND 7 MONTHS POST IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, 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 12647526 ↗
• InjuryAug 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. NO MALFUNCTION OF THE ANNULOPLASTY RING WAS REPORTED. THE PHYSICIAN DECIDED TO REPLACE THE VALVE INSTEAD OF REPAIRING IT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12393572 ↗
• InjuryApr 26, 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 30MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM 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 11725410 ↗
• InjuryNov 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 10 MONTHS POST IMPLANT OF THIS 30 MM MITRAL ANNULOPLASTY RING, 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: No Information

  MAUDE report 10771171 ↗
• InjuryAug 12, 2020Adverse 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 MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED. THE REASON FOR THE REPLACEMENT AND REPLACEMENT PRODUCT WERE NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10395272 ↗