Contegra® 200H18 (UDI 00643169357112)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169357112), received between Oct 31, 2017 and Oct 27, 2023 — classified as 4 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 7 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 3 YEAR OLD PEDIATRIC PATIENT,  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 18024980 ↗
• InjuryFeb 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 5 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A 3 YEARS OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS MIXED LESION PULMONARY STENOSIS AND MODERATE PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 16303490 ↗
• InjuryJan 24, 2022Calcified; Gradient Increase; Calcified; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 10 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A NON MEDTRONIC PRODUCT. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE CONDUIT STENOSIS. IT WAS ALSO REPORTED THAT THE CONDUIT WAS HEAVILY CALCIFIED ESPECIALLY AROUND THE DISTAL ANASTOMOSIS. ALSO, A PEAK GRADIENT OF 65MMHG AND 52MMHG AFTER BALLOON ANGIOPLASTY WERE NOTED ON ECHOCARDIOGRAM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 13335971 ↗
• InjuryOct 31, 2017Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 9 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS AND HIGH GRADIENTS OF THE CONDUIT. IT WAS REPORTED A FEW MONTHS PRIOR TO BEING REPLACED, THE CONDUIT WAS STENTED, HOWEVER, IT RESTENOSED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 6992385 ↗