Contegra® 200H18 (UDI 00613994600301)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00613994600301), received between Jul 2, 2018 and Oct 27, 2023 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 10 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 3 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18024664 ↗
• InjuryJun 22, 2022Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT, IT WAS EXPLANTED AND REPLACED WITH A UNKNOWN VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED HEAVILY CALCIFIED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 14777429 ↗
• InjuryMay 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 11 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A 3 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14338032 ↗
• InjuryOct 20, 2021Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 10 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A PULMONARY 25MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 12667296 ↗
• InjuryAug 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 8 YEARS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12335946 ↗
• InjuryAug 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 4 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) MONTH-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12300363 ↗
• InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 9 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE DEPLOYED TO 22MM. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9792796 ↗
• InjuryAug 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 8 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH AN 18MM TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8925184 ↗
• InjuryJul 30, 2019Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 4 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) YEAR-OLD PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS CALCIFICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8844200 ↗
• InjuryDec 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 10 DAYS POST IMPLANT OF THIS 18MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IN A PEDIATRIC PATIENT, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH A 20MM TRANSCATHETER PULMONARY VALVE (TPV) FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8122031 ↗
• InjuryNov 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 7 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT, IT WAS EXPLANTED AND REPLACED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 8103904 ↗
• InjuryOct 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY VALVE REPLACEMENT WAS ATTEMPTED BUT UNSUCCESSFUL DUE TO INADEQUATE LANDING ZONE WITHIN THE CONDUIT. SUBSEQUENTLY, TWO MONTHS LATER THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 22MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS STENOSIS AND INSUFFICIENCY (REGURGITANT FRACTION 37%) WITH A SEVERELY DILATATED RIGHT VENTRICLE.

  Patient problems: Pulmonary Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 8015393 ↗
• InjuryOct 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS 2 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN THIS PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22MM PULMONARY VALVED CONDUIT DUE TO STENOSIS AND INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 8014999 ↗
• InjuryOct 3, 2018Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS POST IMPLANT OF THIS 18MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IMPLANTED IN A SIX YEAR OLD PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 20MM VALVED CONDUIT. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; No Information; Pulmonary Valve Stenosis

  MAUDE report 7930624 ↗
• InjuryAug 10, 2018Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 4 MONTHS POST IMPLANT OF THIS 18 MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 22 MM VALVED CONDUIT OF A DIFFERENT MODEL DUE TO MODERATE STENOSIS AND CALCIFICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Pulmonary Valve Stenosis

  MAUDE report 7772235 ↗
• InjuryJul 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 3 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, A 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

  MAUDE report 7654219 ↗