Contegra® 200H16 (UDI 00613994600288)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994600288), received between Mar 15, 2017 and May 17, 2023 — 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 4 YEAR OLD PEDIATRIC PATIENT, AN 18MM 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 16945778 ↗
• InjuryMay 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 1 YEAR OLD PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE PULMONARY REGURGITATION (PR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 16911176 ↗
• InjuryJan 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A (B)(6) MONTH OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS DUE TO STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 11135580 ↗
• InjuryAug 6, 2020Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 3 MONTHS POST IMPLANT OF A 16MM PULMONARY VALVED CONDUIT IN A (B)(6)-MONTH-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM PULMONARY VALVED CONDUIT OF A DIFFERENT MODEL. THE REASON FOR EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Valve Stenosis

  MAUDE report 10373408 ↗
• InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF A 16MM PULMONARY VALVED CONDUIT IN A 19-MONTH-OLD PEDIATRIC PATIENT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER IMPLANT WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 10340801 ↗
• InjurySep 11, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A 12-MONTH-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 Valve Stenosis

  MAUDE report 8990074 ↗
• InjuryAug 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS 11 MONTHS POST IMPLANT OF THIS 16MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IMPLANTED IN A PEDIATRIC PATIENT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A 20MM PULMONARY BIOPROSTHETIC VALVED CONDUIT FOR UNKNOWN REASONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 8887437 ↗
• InjuryMay 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IN AN (B)(6) 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: No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 8619709 ↗
• InjuryAug 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS AND TWO MONTHS POST IMPLANT OF THIS BIOPROSTHETIC PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY VALVE (TPV) FOR UNKNOWN REASONS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6793157 ↗
• InjuryMar 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS, ONE MONTH POST IMPLANT OF THIS BIOPROSTHETIC VALVED PULMONIC CONDUIT, THIS DEVICE WAS EXPLANTED AND REPLACED. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; No Information

  MAUDE report 6407443 ↗