Contour 3D® 690R28Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169121683), received between May 3, 2017 and May 15, 2026 — classified as 2 deaths, 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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 30 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗
• InjurySep 9, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE TRICUSPID LEAFLETS WERE NOT COAPTING PROPERLY, LEADING TO HIGH OR SEVERE TRICUSPID REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23006364 ↗
• DeathMar 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT REPRESENTATIVE THAT 1 DAY POST IMPLANT OF THIS 28MM ANNULOPLASTY RING, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE RING COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 21502922 ↗
• InjurySep 11, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. 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 20188535 ↗
• InjuryAug 21, 2024Material Separation; Insufficient Device Problem Information; Intravalvular regurgitation; Material Separation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 3 MONTHS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 20011200 ↗
• InjuryAug 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, A BI-VENTRICULAR 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 19973152 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT AN ELECTROCARDIOGRAM (ECG) DISCOVERED ATRIAL FIBRILLATION (A.FIB). SUBSEQUENTLY 2 DAYS LATER, ELECTRO-CARDIOVERSION WAS PERFORMED. MEDICATION WAS PRESCRIBED AND THE PATIENTS HOSPITAL ADMISSION WAS PROLONGED. FINALLY, 4 DAYS LATER, THE PATIENT WAS DISCHARGED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation

  MAUDE report 18914428 ↗
• InjuryFeb 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR REPLACEMENT WAS THE BAND DISTORTED THE VALVE. IT WAS STATED THAT NO REPLACEMENT DEVICE WAS USED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18640972 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, 29MM MITRAL BIOPROSTHETIC VALVE AND 25MM AORTIC BIOPROSTHETIC VALVE, THE TRICUSPID RING WAS EXPLANTED AND BOVINE PERICARDIUM STRIPS WERE USED TO PERFORM TRICUSPID VALVE FORMING. THE REASON FOR THE REPLACEMENT WAS REPORTED AS LEFT VENTRICULAR FIBRILLATION OCCURRED. IT WAS INDICATED THAT THIS OCCURRED AFTER THE CROSS CLAMP WAS REMOVED FROM THE AORTA AND AFTER MULTIPLE DEFIBRILLATIONS, IT STILL COULD NOT BEAT SO THE AORTA WAS CLAMPED AGAIN. IT WAS INITIALLY SUSPECTED THAT THE SUTURE OF THE TRICUSPID RING WAS TOO DEEP OR THE RING COMPRESSED THE NON-CORONARY VALVE, CAUSING AORTIC INSUFFICIENCY AND CAUSING THE LEFT VENTRICLE TO SWELL AND NOT BEAT. IT WAS REPORTED THAT POST EXPLANT, THE HEART STARTED TO BEAT AUTOMATICALLY AND THE PATIENT IS CURRENTLY IN A STABLE CONDITION. IT WAS FURTHER INDICATED THAT THE AORTIC INSUFFICIENCY RESOLVED POST EXPLANT OF THE TRICUSPID RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Ventricular Fibrillation

  MAUDE report 18425517 ↗
• InjuryNov 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH ANOTHER ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS POOR FORMING EFFECT. IT WAS ALSO REPORTED THAT THE RING WAS FULLY SUTURED AND TESTED PRIOR TO REMOVAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18212374 ↗
• InjuryMay 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING,  THE PATIENT STATED THAT "THEY BEGAN TO BLEED OUT DUE TO SCAR TISSUE AND HAD TO HAVE BYPASS RE-INITIATED AND THEN THEY WERE IN A COMA FOR MULTIPLE DAYS FOLLOWING PROCEDURE BUT HAS OTHERWISE RECOVERED." PATIENT DID NOT STATE SPECIFICALLY WHICH VALVE THEY WERE BLEEDING FROM BUT DID MENTION THEY HAD TWO VALVES WORKED ON. NO INFORMATION ABOUT THE SECOND VALVE IS KNOWN. NO INTERVENTIONS OF THE 28MM TRICUSPID ANNULOPLASTY RING WERE REPORTED.

  Patient problems: Coma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17020510 ↗
• InjuryApr 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 28MM TRICUSPID ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16678527 ↗
• InjuryMar 31, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THIS 28MM TRICUSPID ANNULOPLASTY RING REMAINS IMPLANTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16657247 ↗
• InjuryNov 29, 2022Adverse 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 31MM MITRAL BIOPROSTHETIC VALVE AND 28MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME. IT WAS STATED THAT SUTURE PLACEMENT DURING TRICUSPID REPAIR MAY HAVE POSSIBLY LED TO THE CONDUCTION DISTURBANCE. IT WAS ALSO MENTIONED THAT THE PATIENT HAD NO KNOWN PRE-EXISTING ARRHYTHMIAS PRIOR TO THE HEART VALVE AND ANNULOPLASTY RING IMPLANTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 15876525 ↗
• InjuryJan 10, 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 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO PRODUCT PROBLEM WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 13206006 ↗
• InjuryOct 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12700977 ↗
• DeathOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 28 MM TRICUSPID ANNULOPLASTY RING, THE PATIENT HAD LOW EJECTION FRACTION AND WAS "HAVING A HARD TIME COMING OFF PUMP". IT WAS REPORTED THAT THE PATIENT DIED THE SAME DAY AS THE SURGERY AND THE TRICUSPID RING WAS NOT DEFECTIVE OR THE CAUSE OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED AND THERE WAS NO INFORMATION REPORTED TO SUGGEST THAT MEDTRONIC DEVICES CAUSED OR CONTRIBUTED TO THE DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

  Patient problems: Low Cardiac Output

  MAUDE report 12669110 ↗
• InjuryFeb 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28MM ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11375124 ↗
• InjurySep 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 28 MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 31 MM BIOPROSTHETIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10566839 ↗
• InjuryApr 1, 2020Adverse 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 28MM MITRAL ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 29MM MITRAL BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 9910525 ↗
• InjuryMar 9, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 28MM TRICUSPID ANNULOPLASTY RING, IT WAS REMOVED AND REPLACED WITH A NON-MEDTRONIC DEVICE. THE PHYSICIAN REPORTER HE COULD NOT GET THE VALVE TO BE COMPETENT USING HIS TYPICAL SUTURING TECHNIQUE WITH THE 28MM RING. AN ALTERNATIVE SUTURING TECHNIQUE WAS USED WITH THE REPLACEMENT DEVICE AND THE PATIENT'S VALVE BECAME COMPETENT WHEN TESTED. THE PHYSICIAN REPORTED THE CURVATURE OF THE 28MM RING WAS GREATER THAN NORMAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9805526 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS TRICUSPID ANNULOPLASTY RING WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE FOR UNKNOWN REASONS. THE PATIENT RECEIVED A BIOPROSTHETIC TISSUE VALVE IN THE SAME POSITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040776 ↗