Contour 3D® 690R26Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169121676), received between Oct 27, 2017 and May 25, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (20 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 MONTHS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, A BI-VENTRICULAR DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE BI-VENTRICULAR DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY AND INCOMPLETE ATRIOVENTRICULAR BLOCK (AV). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy; Non specific EKG/ECG Changes

  MAUDE report 25269325 ↗
• InjuryJul 23, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 7 MONTHS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 26MM ANNULOPLASTY RING OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 22577681 ↗
• InjuryMay 1, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 2 YEARS AND 1 MONTH POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, THE PATIENT EXPERIENCED INCREASED DY SPNEA AND A TRANSTHORACIC ECHOCARDIOGRAM (TTE) PERFORMED NOTED SEVERE TRICUSPID INSUFFICIENCY AND DYSFUNCTION. IT WAS ALSO REPORTED THAT THERE IS A POSSIBILITY OF PARTIAL RELEASE OF THE ANNULUS. IT WAS STATED THAT A RE-INTERVENTION WAS NOT PERFORMED DUE TO RISK FOR PATIENT AND CONSERVATIVE TREATMENT WAS CONSIDERED (CARDIAC REVALIDATION, WEIGHT LOSS AND OPTIMAL MEDICAMENTOUS THERAPY). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21944523 ↗
• InjuryJan 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 7 MONTHS POST IMPLANT OF THIS 26MM 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 21274545 ↗
• InjuryJul 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM 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 19645045 ↗
• InjuryMay 2, 2024Adverse 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 ADDITIONAL INFORMATION THAT THIS 26MM TRICUSPID ANNULOPLASTY RING WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS THE "VALVE WAS TOO STENOTIC". IT WAS STATED THAT THE 26MM TRICUSPID ANNULOPLASTY RING DID NOT MALFUNCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Tricuspid Valve Stenosis

  MAUDE report 19230156 ↗
• InjuryMar 15, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 7 YEARS AND 11 MONTHS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING AN ISSUE WITH ONE OF HER LEADS WHICH WAS CAUSING AN ISSUE WITH THE ANNULOPLASTY PRODUCT. THE PATIENT WAS FEELING ILL AND A X-RAY SCAN WAS PERFORMED WHICH SHOWED A RIGHT ATRIAL OR RIGHT VENTRICULAR LEAD DANGLING AND HANGING OUT INSIDE HER HEART NEAR THE TRICUSPID VALVE IS ONE CAUSING ALL THE ISSUE WITH THE ANNULOPLASTY PRODUCT. IT WAS MENTIONED THAT THE PATIENT HAD A PROCEDURE IN 5 MONTHS PRIOR TO CLOSE A HOLE IN THE HEART AND IT WAS INDICATED THAT THE DANGLING LEAD WAS NOT NOTED AT THAT TIME. IT WAS NOTED THAT THE PHYSICIAN INFORMED THE PATIENT THAT THE PACEMAKER "IS DOING ALL THE WORK" AND THE PATIENT ALSO MENTIONED THAT THERE IS AN "EXTREME LEAK ON RIGHT SIDE AND LARGE SIZED BALL," AND "ALL ORGANS ON RIGHT SIDE OF HEART ARE A MESS" AS A RESULT AND THE PATIENT HAS ALREADY HAD OPEN HEART SURGERY TWICE. IT WAS FURTHER REPORTED THAT THE PATIENT IS NOW BEING EVALUATED FOR ANOTHER TRANSCATHETER VALVE- IN-VALVE REPLACEMENT PROCEDURE WHICH IS NEWLY APPROVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 18912789 ↗
• InjuryMar 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM 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 18847287 ↗
• InjuryJun 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM 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 17152230 ↗
• InjuryAug 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM 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 15278586 ↗
• InjuryAug 15, 2022Adverse 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 3 YEARS AND 10 MONTHS POST IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A TRICUSPID ANNULOPLASTY RING OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 15224105 ↗
• InjuryJul 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN PRODUCT. THE REASON FOR THE REPLACEMENT WAS REPORTED AS INAPPROPRIATE COAPTATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14924421 ↗
• InjuryMar 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS REPORTED TO BE DUE TO COMPLICATIONS.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13660823 ↗
• InjuryMay 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11866804 ↗
• InjuryJan 27, 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 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. 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 11236009 ↗
• InjuryDec 8, 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 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM NON-MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10968114 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 26MM TRICUSPID ANNULOPLASTY RING, IT WAS EXPLANTED AND REPLACED WITH A 33MM NON-MEDTRONIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10590300 ↗
• InjuryJan 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS TRICUSPID ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC MITRAL VALVE DUE TO SEVERE TRICUSPID INSUFFICIENCY. NO ADVERSE EVENTS RELATED TO THE ANNULOPLASTY RING WERE REPORTED.

  Patient problems: Tricuspid Insufficiency

  MAUDE report 9559282 ↗
• InjuryJul 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 10 MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. THE REASON FOR VALVE REPLACEMENT WAS REPORTED AS INCREASED PULMONARY HYPERTENSION, RIGHT SIDED HEART FAILURE, AND FLUID RETENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 8784925 ↗
• InjuryJul 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS FOLLOWING THE IMPLANT OF THESE ANNULOPLASTY PRODUCTS, A PERMANENT PACEMAKER WAS IMPLANTED DUE TO ATRIAL FIBRILLATION, ATRIAL FLUTTER AND ATRIAL TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 8778000 ↗
• InjuryApr 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS AND 16 DAYS POST IMPLANT OF THIS 26MM ANNULOPLASTY BAND IN THE MITRAL POSITION AND THIS 26MM ANNULOPLASTY RING IN THE TRICUSPID POSITION, BOTH WERE EXPLANTED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Right Ventricular Dysfunction; Tricuspid Regurgitation

  MAUDE report 8541136 ↗
• InjuryMar 25, 2019Material Frayed; Insufficient Device Problem Information; Material Frayed; Insufficient Device Problem Information

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

  Patient problems: Mitral Regurgitation; No Information

  MAUDE report 8449159 ↗
• InjuryNov 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2.3 MONTHS POST IMPLANT OF THIS ANNULOPLASTY RING IN THE TRICUSPID POSITION, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. AN ECHOCARDIOGRAM SHOWED NO REGURGITATION AFTER IMPLANT, HOWEVER, OVER THE WEEKS, THE PATIENT SHOWED MORE SIGNS OF RIGHT HEART PROBLEMS AND SEVERE TRICUSPID REGURGITATION. THE SURGEON REPORTED THERE WAS NO FAILURE OF THE RING, BUT THAT THE PATIENT'S CONDITION CHANGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Tricuspid Regurgitation

  MAUDE report 7001193 ↗
• InjuryOct 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS ANNULOPLASTY RING, THE RING WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6983658 ↗