Contour 3D® 690R36Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169121720), received between Aug 7, 2017 and Oct 23, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 36MM ANNULOPLASTY RING, SEVERE MITRAL REGURGITATION WAS OBSERVED ON A TRANSTHORACIC ECHOCARDIOGRAM (TTE). ANOTHER TTE APPOINTMENT IS SCHEDULED IN 6 MONTHS FOR A CHECK-UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20513128 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 36MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT HAD A LEFT HEMOTHORAX. IT WAS FURTHER NOTED THAT A LARGE HEMATOMA AT THE APEX OF THE HEMITHORAX WAS DISCOVERED ALONG WITH A FAIR AMOUNT OF SANGUINEOUS FLUID. ASPIRATION WAS PERFORMED TO EVACUATE THE CLOT AND FLUID. 500CC OF ANTIBIOTIC WATER WAS INSTILLED. APPROXIMATELY 1 LITER OF CLOT AND BLOOD WAS EVACUATED. NO EVIDENCE OF ACTIVE BLEEDING WAS NOTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Hemothorax

  MAUDE report 20285808 ↗
• InjuryMar 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 1 WEEK POST IMPLANT OF THIS 36MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT A COMPUTERIZED TOMOGRAPHY (CT) DIAGNOSTIC DISCOVERED THE PATIENT HAD AN EPILEPTIC SEIZURE. MEDICATION WAS ADMINISTERED. IT WAS ALSO REPORTED THAT THE PATIENT WAS ALREADY VERY AGITATED DURING THE NIGHT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Convulsion/Seizure

  MAUDE report 18882072 ↗
• InjuryMar 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 38MM MITRAL ANNULOPLASTY RING AND 36MM TRICUSPID ANNULOPLASTY RING, HEMATOPERICARDIUM WAS REPORTED. IT WAS STATED THAT THE LEFT RETROCARDIAC SPACE WAS OBSERVED TO BE COMPLETELY COMPRESSED ON A CHEST X-RAY. A RE-THORACOTOMY WITH HEMATOMA REMOVAL AND HEMOSTASIS WAS PERFORMED ON THE FOLLOWING DAY. AFTER RETHORACOTOMY, A BLEEDING IN THE AREA OF THE LEFT ATRIAL INCISION WAS NOTED. A BLOOD TRANSFUSION WAS ALSO PERFORMED. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Pericardial Effusion

  MAUDE report 18816542 ↗
• InjuryJan 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS FOLLOWING THE IMPLANT OF THIS TRICUSPID ANNULOPLASTY BAND, THE PATIENT DEVELOPED BRADYCARDIA WITH HEART RATE REPORTED AS 26 BEATS PER MINUTE (BPM). IT WAS REPORTED THAT 1 DAY LATER, A PERMANENT PACEMAKER WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE DISCHARGE ELECTROCARDIOGRAM (ECG) PERFORMED NOTED WIDENED QRS COMPLEXES AND LEFT BUNDLE BRANCH BLOCK (LBBB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 13353097 ↗
• InjuryFeb 12, 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 36MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11323914 ↗
• InjuryApr 19, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT THIS 36MM TRICUSPID ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH A 30MM TRICUSPID ANNULOPLASTY RING OF THE SAME MODEL FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8531116 ↗
• InjuryDec 6, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY AFTER THE IMPLANT OF THIS 36MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A 32MM ANNULOPLASTY RING AS THE FIT WAS INADEQUATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8137986 ↗
• InjuryMar 2, 2018Perivalvular Leak; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Perivalvular Leak; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT BOTH A 36 MM TRICUSPID ANNULOPLASTY RING AND A 32 MM TRICUSPID ANNULOPLASTY RING WERE IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7309905 ↗
• InjuryAug 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED ON THE SAME DAY FOR UNKNOWN REASONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 6772482 ↗