Contegra® 200H14 (UDI 00613994600271)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00613994600271), received between May 4, 2017 and Mar 5, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 10 YEARS AND 6 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVE CONDUIT IMPLANTED IN RIGHT VENTRICLE-PULMONARY ARTERY (RV-PA) POSITION AND IMPLANTED IN A THEN 9 MONTHS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM PULMONARY VALVE CONDUIT IN THE SAME IMPLANT POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24520315 ↗
• InjuryNov 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 2 MONTHS POST IMPLANT OF THIS 14 MM PULMONARY VALVED CONDUIT IN A (B)(6) MONTHS OLD PEDIATRIC PATIENT, A 18 MM 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: No Information

  MAUDE report 10835764 ↗
• InjuryJun 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 2 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10116271 ↗
• InjuryFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) 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: High Blood Pressure/ Hypertension; No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 9758071 ↗
• InjuryNov 14, 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 APPROXIMATELY 10 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT, IT WAS EXPLANTED AND REPLACED WITH A 16MM PULMONARY VALVED CONDUIT FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9321714 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 9 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A 7 MONTH OLD PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 20MM VALVED CONDUIT OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8728019 ↗
• InjurySep 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS AND THREE MONTHS POST IMPLANT OF THIS 14MM PULMONARY BIOPROSTHETIC VALVED CONDUIT, ECHOCARDIOGRAM REVEALED A GRADIENT OF 5-7 MMHG. NO INTERVENTIONS WERE PERFORMED AT THAT TIME. SIX YEARS AND SIX MONTHS POST IMPLANT OF THIS VALVED CONDUIT, A TRANSCATHETER VALVE WAS IMPLANTED VALVE IN VALVE DUE TO A GRADIENT OF 30MMHG, MILD REGURGITATION AND MILD STENOSIS OF THE PROXIMAL PORTION OF THE CONDUIT. THE RIGHT VENTRICLE WAS NOTED TO BE DILATED AND HYPERTENSIVE, WITH MILDLY DEPRESSED FUNCTION AT THIS TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 7917147 ↗
• InjuryMay 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS POST IMPLANT OF THIS 14MM BIOPROSTHETIC PULMONIC VALVED CONDUIT IN A PEDIATRIC PATIENT, THIS VALVE WAS REPLACED WITH A 16MM PULMONIC VALVED CONDUIT. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Valve Stenosis

  MAUDE report 6544525 ↗