Contegra® 200H22 (UDI 00613994600349)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994600349), received between Jun 6, 2017 and Sep 2, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

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

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS, 11 MONTHS POST IMPLANT OF THIS 22MM CONTEGRA PULMONARY VALVED CONDUIT, IT WAS EXPLANTED AND REPLACED WITH A 22MM CONTEGRA PULMONARY VALVE CONDUIT 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 22937594 ↗
• InjuryOct 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 10 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 3 YEAR OLD 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 20432641 ↗
• InjurySep 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 10 MONTHS POST IMPLANT OF THIS  22MM PULMONARY VALVED CONDUIT, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17689502 ↗
• InjuryJan 3, 2023Calcified; Gradient Increase; Calcified; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 9MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT, A BALLOON VALVULOPLASTY OF THE CONDUIT WAS PERFORMED DUE TO STENOSIS. SUBSEQUENTLY 8 YEARS 8 MONTHS LATER, THE PATIENT SUCCESSFULLY HAD A VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV). THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE PULMONARY STENOSIS. IT WAS REPORTED THAT THE 22MM PULMONARY VALVED CONDUIT WAS CALCIFIED. A GRADIENT OF 55MMHG WAS REPORTED AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 16086557 ↗
• InjuryDec 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 7 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 8 YEARS OLD PEDIATRIC PATIENT, 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: Insufficient Information

  MAUDE report 15895202 ↗
• InjuryOct 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 2 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 17 YEAR OLD 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 15655305 ↗
• InjurySep 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 7 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Valve Stenosis

  MAUDE report 9124346 ↗
• InjuryMay 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 1 MONTH POST IMPLANT OF THIS BIOPROSTHETIC PULMONARY VALVED CONDUIT IMPLANTED IN A PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY VALVE (TPV) WAS IMPLANTED VALVE-IN-VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 8647159 ↗
• InjuryMar 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT EIGHT YEARS AND SIX MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IMPLANTED IN A PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY VALVE (TPV) DEPLOYED TO 22MM WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR VALVE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8400789 ↗
• InjuryJun 6, 2017Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS, TWO MONTHS POST IMPLANT OF THIS BIOPROSTHETIC PULMONIC VALVE IN A PEDIATRIC PATIENT, THIS DEVICE WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 6616602 ↗