Contegra® 200H20 (UDI 00613994600325)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994600325), received between Jan 4, 2017 and Mar 28, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 9 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 11 YEAR OLD PEDIATRIC PATIENT, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS MODERATE TO SEVERE PULMONARY REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 18994932 ↗
• InjuryMay 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A THEN 8 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME MODEL AND SIZE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 16885109 ↗
• InjuryNov 16, 2022Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 9 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A 6 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE CALCIFICATION AND STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 15810553 ↗
• InjuryNov 11, 2021Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 12 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A 6 YEARS 9 MONTHS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 12800030 ↗
• InjuryNov 19, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS 1 MONTH POST IMPLANT OF THIS 20MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IN A PEDIATRIC PATIENT, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH AN 18MM TRANSCATHETER PULMONARY VALVE (TPV) FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Valve Stenosis

  MAUDE report 9340720 ↗
• InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY EIGHT YEARS AND ONE MONTH POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IMPLANTED IN A PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE. PRIOR TO REPLACEMENT, THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH WITH EXERCISE. NO SPECIFIC FAILURE MODE OF THE CONDUIT WAS PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea

  MAUDE report 8449669 ↗
• InjuryFeb 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS POST IMPLANT OF THIS 20MM BIOPROSTHETIC VALVED CONDUIT IMPLANTED IN A (B)(6) PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE INSUFFICIENCY AND MILD STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 8302312 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 2 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IN AN (B)(6) PEDIATRIC PATIENT, AN TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 7772092 ↗
• InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 9 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 27MM BIOPROSTHETIC VALVE DUE TO SEVERE STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis; Stenosis

  MAUDE report 7720086 ↗
• InjuryAug 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 7 MONTHS YEARS POST IMPLANT OF THIS BIOPROSTHETIC PULMONARY VALVED CONDUIT, THE DEVICE WAS REPLACED DUE TO BOTH PULMONARY STENOSIS AND PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 6774099 ↗
• InjuryJan 4, 2017Adverse 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 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS PULMONARY BIOPROSTHETIC VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficiency, Valvular; No Information; Pulmonary Valve Stenosis

  MAUDE report 6221978 ↗