Contour 3D® 690R30Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00643169121690), received between Jun 26, 2018 and Aug 18, 2026 — classified as 1 death, 48 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 50 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Insufficient Device Problem Information

  Medtronic received information that 12 days post implant of this 30mm tricuspid annuloplasty ring, it was explanted and replaced with a 31mm mitral bioprosthetic valve in the same position. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50303730 ↗
• InjuryApr 22, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM CONTOUR 3D ANNULOPLASTY HEART RING, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MDT PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED DUE TO THE RING BEING DAMAGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24954661 ↗
• InjuryApr 20, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS POST IMPLANT OF THIS 30MM CONTOUR 3D ANNULOPLASTY HEART RING, THE PATIENT WAS EXPERIENCING BIFASCICULAR BLOCK, WHICH RESULTED IN HOSPITALIZATION. TELEMETRY WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24925756 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT OF THE 30MM TRICUSPID ANNULOPLASTY RING WAS RESIDUAL RE GURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24349603 ↗
• InjuryFeb 16, 2026Structural Problem; Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY RING. THE REASON FOR THE REPLACEMENT WAS REPORTED AS IMPROPER LEAFLET COAPTATION AND AND A DEFECT IN THE STRUCTURE OF THE RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24345241 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 MONTHS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, 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 24143566 ↗
• InjuryJan 15, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 11 MONTHS POST IMPLANT OF THIS 30MM TRICUSPID HEART RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS LOW EJECTION FRACTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24078109 ↗
• InjuryDec 30, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE ANNULOPLASTY RING WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. IT WAS ALSO NOTED THAT THE REPLACEMENT DEVICE WAS A 29MM BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23926296 ↗
• InjuryOct 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 DAYS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23347162 ↗
• InjurySep 9, 2025Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY AND HISTORY OF SPONTANEOUS SUSTAINED VENTRICULAR TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Tachycardia

  MAUDE report 23006450 ↗
• MalfunctionSep 4, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT AN ECHOCARDIOGRAM DISCOVERED MODERATE TRICUSPID REGRUGITATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22962611 ↗
• InjuryAug 26, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN ANNULOPLASTY PRODUCT OF THE SAME SIZE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE ANNULOPLASTY DID NOT MATCH THE PATIENT'S TRICUSPID ANNULUS MORPHOLOGY. WATER TESTS WERE COMPLETED, AND THE EFFECT WAS POOR WITH MODERATE TO SEVERE TRICUSPID REGURGITATION AND PROLAPSE. THE ANNULOPLASTY BAND WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22899021 ↗
• InjuryJun 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 WEEK POST IMPLANT OF THIS 28MM PROFILE 3D RING AND 30MM CONTOUR 3D RING, 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: Insufficient Information

  MAUDE report 22217484 ↗
• InjuryMar 10, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

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

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21566552 ↗
• InjuryFeb 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA AND ATRIAL ARRHYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION AND ATRIAL FLUTTER). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21381234 ↗
• DeathJan 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A POSTOPERATIVE DEATH OCCURRED FOLLOWING THE IMPLANTATION OF A 30MM CONTOUR 3D TRICUSPID ANNULOPLASTY RING. THE CAUSE OF DEATH IS UNKNOWN. THERE WERE NO ALLEGED PRODUCT ISSUES REPORTED. THE DEVICE REMAINS IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21063029 ↗
• InjuryDec 6, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 5 MONTHS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, SEVERE TRICUSPID REGURGITATION WAS NOTED. IT WAS REPORTED THAT PERCUTANEOUS TRICUSPID VALVE RECONSTRUCTION USING TRICLIP IMPLANTATION BETWEEN THE SEPTAL AND POSTERIOR TRICUSPID NATIVE VALVE LEAFLET WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 20865389 ↗
• InjuryOct 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 30 MM TRICUSPID ANNULOPLASTY RING AND 30 MM 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 20449253 ↗
• InjurySep 5, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE TRICUSPID REGURGITATION DUE TO THE PATIENTS NATIVE LEAFLET NOT COAPTING PROPERLY. IT WAS STATED THAT THE 30MM TRICUSPID ANNULOPLASTY RING MALFUNCTIONED. NO ADDITIONALADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 20147947 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED TO BE "WASTED" AND "IN/OUT". IT WAS REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 18922266 ↗
• InjuryMar 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18907507 ↗
• InjuryMar 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT A COMPUTERIZED TOMOGRAPHY (CT) SCAN DISCOVERED A SUBDURAL HEMATOMA. IT WAS ALSO REPORTED THAT THE HEMATOMA WAS LOCATED IN THE FRONTOPARIETAL RIGHT AND FRONTAL LEFT AND PARAFACIAL. AN UNKNOWN INTERVENTION OCCURRED HOWEVER THE DEVICE REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 18838031 ↗
• InjuryFeb 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE OCCLUSION OF THE RIGHT CORONARY ARTERY WAS NOT DUE TO A MEDTRONIC DE VICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Pericardial Effusion

  MAUDE report 18677515 ↗
• InjuryJan 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 MONTHS POST IMPLANT OF THIS 30MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 42MM ANNULOPLASTY BAND OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18475446 ↗
• InjurySep 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM TRICUSPID 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 17808114 ↗