Contegra® 200H20 (UDI 00643169616936)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169616936), received between Jul 23, 2018 and Nov 26, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 8 DAYS POST IMPLANT OF THIS 20MM PULMONARY VALVE CONDUIT, IT WAS EXPLANTED AND REPLACED WITH A 20MM PULMONARY VALVE CONDUIT OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23659342 ↗
• InjuryAug 8, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 5 YEAR OLD PEDIATRIC PATIENT, IT WAS REPORTED THAT THE PATIENT HAD ENDOCARDITIS. IT WAS REPORTED THAT THE PATIENT HAD A FEVER AND INFLAMMATION. AN ECH OCARDIOGRAM (ECHO) DISCOVERED AN ECHOGENIC STRUCTURE ON THE CONDUIT VALVE SUSPICIOUS FOR ENDOCARDITIS. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ANTIBIOTICS WERE PRESCRIBED. IT WAS REPORTED THAT THE KARIUS TEST AND BLOOD CULTURES PERFORMED WERE BOTH NEGATIVE FOR ANY PATHOGENS. IT WAS ALSO STATED THAT THE CONDUIT DEVICE WAS PREPPED FOR IMPLANTATION ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE (IFU). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Fever

  MAUDE report 19936806 ↗
• MalfunctionAug 31, 2023Expiration Date Error; Expiration Date Error

  MEDTRONIC RECEIVED INFORMATION THAT A 20MM PULMONARY VALVED CONDUIT WAS IMPLANTED TWO DAYS PAST ITS USE BEFORE DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17661829 ↗
• InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, THE PATIENT DEVELOPED COMPLETE HEART BLOCK (CHB). TEMPORARY ATRIOVENTRICULAR PACING WAS INITIATED. ULTIMATELY 8 DAYS POST IMPLANT, A PERMANENT PACEMAKER WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 11199122 ↗
• InjuryNov 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS AND 6 DAYS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IMPLANTED IN THE MITRAL POSITION OF A (B)(6)-MONTH-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: Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis; No Information

  MAUDE report 10809714 ↗
• InjuryNov 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS 2 MONTHS POST IMPLANT OF THIS 20 MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IMPLANTED IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A 22 MM PULMONARY BIOPROSTHETIC VALVED CONDUIT OF THE SAME MODEL FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9321985 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 DAYS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IN THIS PEDIATRIC PATIENT, A PERMANENT PACE MAKER WAS IMPLANTED DUE TO ATRIO-VENTRICULAR (AV) BLOCK, 3RD DEGREE COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block; No Code Available

  MAUDE report 7710750 ↗