Contegra® 200SH20 (UDI 00643169616875)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169616875), received between Mar 24, 2017 and Jun 2, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Gradient Increase” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 8 YEAR OLD PEDIATRIC PATIENT, A 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 25360952 ↗
• InjuryOct 20, 2025Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND POST IMPLANT OF THIS 20MM CONTEGRA PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 4 YEAR OLD PEDIATRIC PATIENT, IT WAS REPLACED WITH A TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS MODERATE PULMONARY STENOSIS, MODERATE PULMONARY REGURGITATION AND A MEAN GRADIENT OF 24MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23342832 ↗
• InjuryJun 3, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 20 MM PULMONARY VALVED CONDUIT IN A 11YR 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 14598550 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 DAYS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT THIS PATIENT RECEIVED A PERMANENT PACEMAKER DUE TO ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 9224918 ↗
• InjuryJul 1, 2019Adverse 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 20MM BIOPROSTHETIC PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC PULMONARY VALVED CONDUIT OF THE SAME SIZE AND MODEL FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Adhesion(s); No Information

  MAUDE report 8749380 ↗
• InjuryApr 25, 2018Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS AND HIGH GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 7462127 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS PULMONARY BIOPROSTHETIC VALVED CONDUIT A PERMANENT PACEMAKER IMPLANT WAS REQUIRED. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 6432210 ↗