Contour 3DRecalls & reported problems across all models

We found 12 models of Contour 3D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 188 adverse event reports in the FDA's MAUDE database, received between May 3, 2017 and Aug 18, 2026 — classified as 7 deaths, 175 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (93 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Contour 3D problems

Contour 3D models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Contour 3D® 690R30

  RING, ANNULOPLASTY
  1 death50 reports
• Contour 3D® 690R32

  RING, ANNULOPLASTY
  3 deaths40 reports
• Contour 3D® 690R28

  RING, ANNULOPLASTY
  2 deaths30 reports
• Contour 3D® 690R26

  RING, ANNULOPLASTY
  24 reports
• Contour 3D® 690R34

  RING, ANNULOPLASTY
  1 death23 reports
• Contour 3D® 690R36

  RING, ANNULOPLASTY
  10 reports
• Contour 3D™ 690R26

  RING, ANNULOPLASTY
  4 reports
• Contour 3D™ 690R28

  RING, ANNULOPLASTY
  2 reports
• Contour 3D™ 690R34

  RING, ANNULOPLASTY
  2 reports
• Contour 3D™ 690R30

  RING, ANNULOPLASTY
  1 report
• Contour 3D™ 690R32

  RING, ANNULOPLASTY
  1 report
• Contour 3D™ 690R36

  RING, ANNULOPLASTY
  1 report

Recent Contour 3D adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryMay 25, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 MONTHS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, A BI-VENTRICULAR DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE BI-VENTRICULAR DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY AND INCOMPLETE ATRIOVENTRICULAR BLOCK (AV). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Non specific EKG/ECG Changes

  MAUDE report 25269325 ↗
• InjuryMay 15, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT DURING A TRICUSPID VALVE REPAIR USING THIS 28 MM TRICUSPID ANNULOPLASTY RING, AFTER IMPLANTATION, INTRAOPERATIVE SALINE TESTS WERE PERFORMED AND REGURGITATION WAS OBSERVED AT THE COMMISSURE BETWEEN THE ANTERIOR AND POSTERIOR TRICUSPID NATIVE VALVE LEAFLETS. THE PHYSICIAN ALLEGED A QUALITY ISSUE WITH THE 28 MM TRICUSPID ANNULOPLASTY RING AND ATTRIBUTED AN UNSUCCESSFUL TRICUSPID VALVE REPAIR TO THE RING. IT WAS REPORTED THAT THE 28 MM TRICUSPID ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH AN ANNULOPLASTY RING FROM ANOTHER MANUFACTURER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 25183465 ↗
• MalfunctionMay 11, 2026Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 4 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DISCOVERED SEVERE STENOSIS. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Stenosis

  MAUDE report 25138128 ↗
• 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 ↗
• InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS NON-COAPTING LEAFLETS. THE PROCEDURE TIME WAS PROLONGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24793014 ↗
• InjuryFeb 25, 2026Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING FOR MODERATE NATIVE TRICUSPID VALVE INSUFFICIENCY, IT WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS DURING THE WATER TEST, IT WAS DISCOVERED THAT THE PATIENT'S NATIVE LEAFLETS COULD NOT ALIGN, AS THE ANNULUS WAS TOO LARGE. THEREFORE, THE ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY RING. IT WAS FURTHER REPORTED THAT A WATER TEST OF THE 28MM ANNULOPLASTY RING WAS PERFORMED AND SHOWED PERFECT ALIGNMENT OF THE LEAFLETS. IT WAS FURTHER NOTED THAT THE ANNULOPLASTY RING DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24443909 ↗
• 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 ↗
• MalfunctionJan 16, 2026Particulates; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE FOREIGN OBJECT LOOKED TO BE MADE OF SUTURE MATERIAL. IT WAS FURTHER NOTED THAT THAT THE OBJECT WAS FOUND ON THE ANNULOPLASTY RING WITHIN THE PACKAGING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24092290 ↗
• 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 ↗

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