Contegra® 200H16 (UDI 00613994600295)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994600295), received between Nov 26, 2018 and Dec 2, 2019 — classified as 3 injuries.

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

• InjuryDec 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, AN 16MM 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: Calcium Deposits/Calcification; No Information; Pulmonary Valve Stenosis

  MAUDE report 9394925 ↗
• InjuryMay 15, 2019Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A (B)(6) PATIENT, A TRANSCATHETER PULMONARY VALVE (TPV) DEPLOYED TO 22MM WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR VALVE REPLACEMENT WAS DUE TO INCREASED GRADIENTS ALONG WITH SEVERE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Regurgitation

  MAUDE report 8612721 ↗
• InjuryNov 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS AND ONE MONTH POST IMPLANT OF THIS 16MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IMPLANTED IN A TWO YEAR OLD PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME SIZE AND MODEL. THE REASON FOR EXPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8101517 ↗