Contegra® 200H14 (UDI 00643169298637)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169298637), received between Nov 10, 2017 and Dec 8, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 8 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A 2 YEAR 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: Insufficient Information

  MAUDE report 15945611 ↗
• InjuryApr 7, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 9 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN AN 8-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: Insufficient Information

  MAUDE report 11627770 ↗
• InjuryJan 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 4 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A 10 MONTHS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11174354 ↗
• InjuryJun 3, 2019Calcified; Material Erosion; Stretched; Material Split, Cut or Torn; Calcified; Material Erosion; Stretched; Material Split, Cut or Torn

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 3 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A PEDIATRIC PATIENT, THE CONDUIT WAS DILATED TO OVER 23-24CM AND WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Corneal Pannus; No Information

  MAUDE report 8662987 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) OLD PEDIATRIC PATIENT, AN 18MM 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: No Information

  MAUDE report 7810162 ↗
• InjuryNov 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE YEAR FIVE MONTHS POST IMPLANT OF THIS 14 MM PULMONARY BIOPROSTHETIC VALVED CONDUIT IMPLANTED IN A PEDIATRIC PATIENT, THE DEVICE WAS EXPLANTED AND REPLACED WITH A 16 MM PULMONARY BIOPROSTHETIC VALVED CONDUIT FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 7018819 ↗