Contour 3D® 690R32Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00643169121706), received between Feb 13, 2018 and Feb 25, 2026 — classified as 3 deaths, 35 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 40 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 12 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22938036 ↗
• DeathApr 24, 2025Adverse 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 4 YEARS AND 1 MONTH POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE ANNULOPLASTY RING COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information; Pneumonia

  MAUDE report 21900972 ↗
• InjuryFeb 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THESE PROFILE 3D AND CONTOUR 3D ANNULOPLASTY RINGS, 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 21363156 ↗
• InjuryJan 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING AND 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR CHRONIC CEREBRAL ATROPHY AND HAD EXPERIENCED MULTIPLE FALLS, WEAKNESS AND SLURRED SPEECH. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21061078 ↗
• MalfunctionJan 2, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT AN ECHOCARDIOGRAM SHOWED THE PRESENCE OF RESIDUAL TRICUSPID INSUFFICIENCY AND TRICUSPID STENOSIS. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation; Tricuspid Valve Stenosis

  MAUDE report 21054901 ↗
• InjuryJan 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 9 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING AND 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain

  MAUDE report 21054304 ↗
• InjuryJan 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING AND 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR 2 DAYS WITH CHEST PAIN. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain

  MAUDE report 21054206 ↗
• InjuryOct 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE AND 32MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADYCARDIA/TACHYCARDIA SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20471958 ↗
• InjuryOct 7, 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 ON THE SAME DAY AS THE IMPLANT DATE OF THIS 32MM TRICUSPID ANNULOPLASTY RING, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20385704 ↗
• InjuryJul 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK WAS NOTED. SUBSEQUENTLY, 15 DAYS LATER, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND IMPLANT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 19794382 ↗
• InjuryApr 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A RING OF THE SAME MODEL AND SIZE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE RING WAS NOT FITTING PROPERLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19135063 ↗
• InjuryApr 10, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED MODERATE TRICUSPID VALVE REGURGITATION. IT WAS REPORTED THAT 6 MONTHS LATER, A SECOND ECHOCARDIOGRAM WAS PERFORMED WHICH SHOWED SEVERE TRICUSPID REGURGITATION (TR). NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 19077840 ↗
• InjuryMar 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 30MM MITRAL ANNULOPLASTY RING AND THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT DEVELOPED THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK. IT WAS ALSO REPORTED THAT TEMPORARY PACING WAS PROVIDED, THE AV BLOCK WAS TRANSIENT AND NO PERMANENT PACEMAKER WAS NEEDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 18904318 ↗
• InjuryMar 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 WEEKS AND 6 DAYS POST IMPLANT OF THIS 32MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A DIFFERENT MANUFACTURERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS LEFT VENTRICULAR PSEUDOANEURYSM. A 32MM TRICUSPID ANNULOPLASTY RING WAS ALSO IMPLANTED CONCOMITANTLY DURING THE INITIAL IMPLANT PROCEDURE. IT WAS ALSO REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED PERICARDIAL EFFUSION. THE PATIENTS HOSPITAL ADMISSION WAS PROLONGED AND A BLOOD TRANSFUSION WAS ADMINISTERED. IT WAS ALSO REPORTED THAT 2 DAYS PRIOR TO THE REPLACEMENT, THE ATRIOVENTRICULAR GROOVE WAS RUPTURED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pericardial Effusion

  MAUDE report 18871315 ↗
• InjuryFeb 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 12 HOURS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT HAD ACQUIRED AFIBRINOGENEMIA TEMPORARY BLOOD CLOTTING DISORDER. SUBSEQUENTLY 1 DAY LATER, A BLOOD TEST DISCOVERED A THROMBIN TIME OF 45 SECONDS. THE PATIENT WAS TREATED WITH A TRANSFUSION OF 1000IE OF PROTHROMBIN-PROCONVERTIN-STUART-FACTOR (PPSB), 4G OF FIBRINOGEN AND 4 UNITS OF FRESH FROZEN PLASMA (FFP). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Anemia

  MAUDE report 18812964 ↗
• InjuryFeb 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE PATIENTS NATIVE VALVE LEAFLETS WERE NOT COAPTING EFFICIENTLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18669976 ↗
• InjuryJan 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 32MM 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 18476028 ↗
• InjuryDec 7, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 32MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS A DEFORMATION OF THE SHAPE OF THE ANNULOPLASTY RING WAS OBSERVED DURING SUTURING. IT WAS STATED THAT THE ANNULOPLASTY PRODUCT HAD BEEN FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18282793 ↗
• InjuryMay 30, 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 32MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MEDTRONIC DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS POOR EFFECT OF THE RING. IT WAS LATER STATED THAT THIS WAS REFERRING TO A FAILURE OF THE RING TO ACHIEVE A FORMING EFFECT. IT WAS REPORTED THAT THE ANNULOPLASTY PRODUCT DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17020580 ↗
• InjuryMay 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS POST IMPLANT OF THIS 32MM TRICUSPID  ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 30MM ANNULOPLASTY RING. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16939259 ↗
• InjuryMar 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 12 MONTHS POST IMPLANT OF THIS 34MM MITRAL ANNULOPLASTY RING AND 32MM TRICUSPID ANNULOPLASTY RING, THE PATIENT WAS ADMITTED DUE TO SUSPICION OF CARDIAC DECOMPENSATION. SYMPTOMS INCLUDED EDEMA, PRESYNCOPE, DIZZINESS AND SCLERAL JAUNDICE. IT WAS REPORTED THAT MODERATE TO SEVERE MITRAL REGURGITATION WAS OBSERVED UPON PERFORMING A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). A DIAGNOSTIC BLOOD TEST WAS PERFORMED AND DISCOVERED A HEMOGLOBIN OF 6.9 G/DL OR ANEMIA. A BLOOD TRANSFUSION WAS GIVEN. ONE DAY LATER, AN ECHOCARDIOGRAM (ECHO) AND TEE DISCOVERED MILD TO MODERATE TRICUSPID REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Anemia; Dizziness; Jaundice; Presyncope; Swelling/ Edema; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 16568272 ↗
• InjuryJan 31, 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 32MM ANNULOPLASTY RING, THIRD-DEGREE ATRIOVENTRICULAR (AV) BLOCK WAS NOTED ON ELECTROCARDIOGRAM (ECG)  AND A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 13392948 ↗
• DeathDec 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ON THIS PATIENT PASSED AWAY ON SAME DAY AS THE IMPLANT DAY OF THIS 32MM ANNULOPLASTY RING. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE IS NO EVIDENCE TO SUGGEST THAT THE ANNULOPLASTY RING CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 12934623 ↗
• DeathNov 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY DEVICE, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. THERE IS NO INFORMATION TO SUGGEST THE MEDTRONIC DEVICE CAUSED OR CONTRIBUTED TO THE DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 12851786 ↗