Contour 3D® 690R34Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169121713), received between Jun 11, 2018 and Jun 2, 2025 — classified as 1 death, 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE RING ANNULOPLSTY TRICUSP CONTOUR 3D 34MM, TRICUSPID REPAIR FAILURE OCCURRED AND THE RING WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22128132 ↗
• InjuryJul 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE AND 34MM TRICUSPID ANNULOPLASTY RING, A REPLACEMENT PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIO-VENTRICULAR BLOCK (AVB), ATRIAL TACHYCARDIA, ATRIAL FLUTTER AND ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19708754 ↗
• InjuryJul 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 5 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE AND 34MM TRICUSPID ANNULOPLASTY RING, A REPLACEMENT PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB), ATRIAL TACHYCARDIA, ATRIAL FLUTTER AND ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 19708703 ↗
• InjuryMay 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, PULMONARY EDEMA WAS OBSERVED ON A CHEST X-RAY SHORTLY AFTER ADMISSION TO THE INTENSIVE CARE UNIT AND THE PATIENT HAD BECOME INCREASINGLY UNSTABLE. TREATMENT WAS ADMINISTERED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Edema

  MAUDE report 19221911 ↗
• InjuryApr 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, A PLEURAL EFFUSION WAS OBSERVED ON A CHEST X-RAY. A PUNCTURE TO DRAIN APPROXIMATELY 1500 ML OF BLOOD-SEROUS FLUID WAS PERFORMED. IT WAS STATED THAT IT WAS POSSIBLY RELATED TO DEVICE AND IMPLANT PROCEDURE DUE TO SURGICAL INTERVENTION ON THE HEART CAVITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pleural Effusion

  MAUDE report 19190432 ↗
• InjuryMar 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 34 TRICUSPID ANNULOPLASTY RING, COMPLETE HEART BLOCK (CHB) WAS OBSERVED ON A ELECTROCARDIOGRAM (ECG). IT WAS STATED THAT IT WAS TRANSIENT AND THAT THERE WAS NO INDICATION FOR A PACEMAKER IMPLANTATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18824684 ↗
• InjuryFeb 7, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING AND 36MM MITRAL ANNULOPLASTY RING, IT WAS REPORTED THAT AN ELECTROCARDIOGRAM (ECG) DISCOVERED ATRIO-VENTRICULAR BLOCK III (AV BLOCK III). SUBSEQUENTLY 5 DAYS LATER, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS AV BLOCK III. IT WAS ALSO REPORTED THAT THE PATIENTS HOSPITAL ADMISSION WAS PROLONGED DUE TO THIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18663201 ↗
• DeathJan 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 DAY POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, THE PATIENT DIED. IT WAS REPORTED THAT ON THE SAME DAY POST IMPLANT OF THE DEVICE, A ECHOCARDIOGRAM (ECHO) DISCOVERED PERICARDIAL TAMPONADE. IT WAS ALSO REPORTED THAT THE PATIENT REQUIRED RESUSCITATION DURING THE TRANSFER FROM THE OPERATING ROOM TO THE SURGICAL AFTERCARE ROOM. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DISCOVERED BIVENTRICULAR PUMP FAILURE AND TAMPONADE. EMERGENCY RE-OPERATION WITH A MEDIAN STERNOTOMY AND THORACOTOMY OCCURRED. MODERATE AMOUNTS OF FRESH BLOOD WERE DRAINED. IT WAS DISCOVERED THAT A MYOCARDIAL RUPTURE THAT WAS CAUSED BY CARDIAC MASSAGE WAS FOUND IN THE AREA OF THE POSTERIOR WALL. IT WAS ATTEMPTED TO SUTURE THE MYOCARDIUM, HOWEVER, IT WAS STATED THAT THIS WAS DIFFICULT DUE TO THE UNSUSTAINABLE TISSUE CONDITIONS. THE CAUSE OF DEATH WAS INDICATED TO BE DUE TO PERICARDIAL TAMPONADE. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Cardiac Tamponade; Rupture

  MAUDE report 18535359 ↗
• InjuryOct 4, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 DAYS  POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY VALVE, THE PATIENT WAS GIVEN ORAL ANTICOAGULANT MEDICATION. THE REASON FOR MEDICATION WAS REPORTED AS ATRIAL FLUTTER NOTED ON ELECTROCARDIOGRAM (ECG). THE HEALTH CARE PROFESSIONAL (HCP) STATED THAT THE ISSUE MIGHT HAVE BEEN CAUSED BY STITCHES ITSELF FOLLOWING IMPLANTATION OF THE RING OR DUE TO THE STIFFNESS OF THE RING. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Flutter

  MAUDE report 17870131 ↗
• InjuryMay 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM 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 16940507 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME BRAND. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS STATED THAT THE PRODUCT DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16794592 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT DEVELOPED ELEVATED BODY TEMPERATURE, INCREASED INFECTION PARAMETERS AND WAS HOSPITALIZED. ONE WEEK LATER, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED NOTED "SMALL FLOATING PARTICLES" ON BOTH NATIVE VALVE LEAFLETS AND A DIAGNOSTIC BLOOD TEST PERFORMED NOTED AN INCREASE IN THE WHITE BLOOD CELL COUNT. IT WAS REPORTED THAT A MICROBIOLOGY CULTURE WAS ALSO PERFORMED, HOWEVER THE RESULTS ARE PENDING AND ENDOCARDITIS IS SUSPECTED. THE PATIENT IS BEING TREATED WITH INTRAVENOUS ANTIBIOTICS. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVES TREATMENT FROM A CENTRAL VENOUS CATHETER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 16014112 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM BIOPROSTHETIC VALVE INDICATED FOR THE MITRAL POSITION. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE ECCENTRIC TRICUSPID VALVE REGURGITATION.  IT WAS NOTED THAT THE PATIENTS NATIVE VALVE WAS OBSERVED TO HAVE A LARGE ANTERIOR LEAFLET DEFECT FROM PREVIOUS ENDOCARDITIS LEAVING ONLY A THIN RIM OF TISSUE ON THE LEAFLET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 15842028 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IN AN UNKNOWN DURATION POST IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY BAND, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS THIRD DEGREE ATRIOVENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 15527844 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 34 MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS THIRD DEGREE ATRIOVENTRICULAR (AV) BLOCK. IT WAS ALSO REPORTED THAT ATRIAL FIBRILLATION WAS NOTED AT BASELINE PRIOR TO IMPLANT OF THIS 34 MM TRICUSPID ANNULOPLASTY RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Heart Block

  MAUDE report 15417435 ↗
• InjuryNov 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 DAYS POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER (PPM) WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS ATRIAL FIBRILLATION WHICH LED TO REQUIRING EPICARDIAL PACING AND EVENTUALLY A PPM WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 12836148 ↗
• InjuryMay 20, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTSWERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11860601 ↗
• InjuryMay 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 34MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM TRICUSPID ANNULOPLASTY RING. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11841540 ↗
• InjuryJun 4, 2019Adverse 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 IMMEDIATELY POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Information

  MAUDE report 8667261 ↗
• InjuryMay 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8617002 ↗
• InjuryMay 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 34MM TRICUSPID ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH A 33MM NON MEDTRONIC BIOPROSTHETIC VALVE DUE TO THE RING FAILING TO REPAIR THE TRICUSPID. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8574900 ↗
• MalfunctionAug 21, 2018Off-Label Use; Off-Label Use

  MEDTRONIC RECEIVED INFORMATION THAT THIS ANNULOPLASTY RING WAS IMPLANTED AFTER THE EXPIRATION DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7801233 ↗
• InjuryJun 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY AFTER IMPLANTING THIS 34MM ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Tricuspid Regurgitation

  MAUDE report 7586826 ↗