Contegra® 200H16 (UDI 00643169616912)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00643169616912), received between Dec 13, 2018 and Sep 30, 2026 — classified as 17 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  Medtronic received information that 11 days post implant of this 16mm contegra pulmonary valved conduit, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as complete heart block (CHB). No additional adverse patient effects were reported.

  Patient problems: Heart Block

  MAUDE report 50942944 ↗
• InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVE CONDUIT IMPLANTED IN A 5 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A NEW 16MM PULMONARY VALVE CONDUIT OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25328118 ↗
• InjuryMay 13, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS STENOSIS AND ENDOCARDITIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Pulmonary Valve Stenosis

  MAUDE report 22010685 ↗
• MalfunctionNov 14, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 2 YEAR OLD PEDIATRIC PATIENT, IT WAS REPORTED THAT AN ECHOCARDIOGRAM (ECHO) DISCOVERED MODERATE PULMONARY REGURGITATION. SUBSEQUENTLY, 1 MONTH LATER, A SECOND ECHO WAS PERFORMED AND REMAINED UNCHANGED AS MODERATE PULMONARY REGURGITATION WAS STILL PRESENT. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 20686987 ↗
• InjuryAug 12, 2024Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 9 YEARS, 5 MONTHS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS MODERATE TO SEVERE PULMONARY STENOSIS AND A PEAK GRADIENT OF 70.38MMHG WITH A MEAN GRADIENT OF 43.1MMHG. IT WAS ALSO REPORTED THAT 2 YEARS AND 5 MONTHS POST IMPLANT, THE PATIENT EXPERIENCED METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA) ENDOCARDITIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED..

  Patient problems: Endocarditis; Pulmonary Valve Stenosis

  MAUDE report 19962518 ↗
• InjuryMar 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 2 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM 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 18846604 ↗
• InjuryDec 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A 1 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME MODEL AND SIZE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15894353 ↗
• InjuryNov 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 16MM 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 15718972 ↗
• InjurySep 14, 2022Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A 3 OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 21MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Pulmonary Valve Stenosis

  MAUDE report 15422148 ↗
• InjurySep 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 10 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A 7 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22MM 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 15350967 ↗
• InjuryMay 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT, IT WAS EXPLANTED AND REPLACED WITH A CONDUIT OF THE SAME SIZE AND MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11764196 ↗
• InjuryApr 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 3 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 21MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11721112 ↗
• InjuryFeb 4, 2021Calcified; Gradient Increase; Calcified; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 5 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH AN 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS CONDUIT CALCIFICATION WITH PULMONARY STENOSIS, A PEAK GRADIENT OF 75MMHG, A MEAN GRADIENT OF 42MMHG, AND CENTRAL PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 11278985 ↗
• InjuryJan 11, 2021Gradient Increase; Incomplete Coaptation; Insufficient Device Problem Information; Gradient Increase; Incomplete Coaptation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A 10-MONTH-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM CONDUIT OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 11149963 ↗
• InjuryDec 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 14 DAYS POST IMPLANT OF THIS 16 MM PULMONARY VALVED CONDUIT IN A (B)(6) YEAR AND (B)(6) MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20 MM 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 11037432 ↗
• InjuryApr 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A (B)(6) OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM 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 9927381 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 16MM PULMONARY VALVED CONDUIT WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE IN THIS PEDIATRIC PATIENT, AND REPLACED WITH AN 18MM PULMONARY VALVED CONDUIT FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8821987 ↗
• InjuryDec 13, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 20MM VALVED 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 8162173 ↗