Contour 3D™ 690R26Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994845320), received between Aug 17, 2018 and Dec 12, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2024Appropriate 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 6 DAYS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK OR COMPLETE HEART BLOCK AND ATRIAL ARRHYTHMIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block; Insufficient Information

  MAUDE report 20919404 ↗
• InjuryNov 21, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 26MM MITRAL ANNULOPLASTY RING AND 26MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20751939 ↗
• InjuryNov 20, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE TRICUSPID REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 20735330 ↗
• InjuryAug 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 7 MONTHS POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC DEVICE FOR UNKNOWN REASONS. THE MITRAL BIOPROSTHETIC VALVE WAS ALSO REPLACED AT THE SAME TIME FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7792676 ↗