Contegra® 200H18 (UDI 00643169616929)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169616929), received between Mar 19, 2020 and Sep 30, 2026 — classified as 11 injuries, 1 malfunction.

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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  Medtronic received information that post implant of this 18mm pulmonary valved conduit on the same day, a Bi-Ventricular pacemaker was implanted. The reason for the Bi-Ventricular pacemaker was reported as complete heart block (CHB). No additional adverse patient effects were reported.

  Patient problems: Heart Block

  MAUDE report 50942975 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  Medtronic received information that during the implant of this 18mm pulmonary valved conduit in then a 4 year old pediatric patient, 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 50867050 ↗
• InjuryMar 10, 2026Device Stenosis

  IT WAS REPORTED THAT 7 YEARS AND 2 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVE CONDUIT IMPLANTED IN A THEN 4 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD PULMONARY STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 24560994 ↗
• InjuryFeb 10, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVE CONDUIT IMPLANTED IN A THEN 2-YEAR-OLD PEDIATRIC PATIENT, A 16MM PULMONARY 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 24305207 ↗
• MalfunctionNov 5, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 1 YEAR OLD PEDIATRIC PATIENT, IT WAS REPORTED THAT THE DISCHARGE ECHOCARDIOGRAM (ECHO) DISCOVERED CONDUIT REDUNDANCY AND PROLAPSE BACK INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). IT WAS ALSO REPORTED THAT THERE IS MILD TO MODERATE PULMONARY REGURGITATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT AFFECTS WERE REPORTED.

  Patient problems: Aneurysm; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 20612803 ↗
• InjuryMay 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 4 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 19310848 ↗
• InjurySep 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 9 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 4 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 17711713 ↗
• InjuryJun 16, 2022Adverse 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 AN UNKNOWN DURATION POST IMPLANT OF THIS 18 MM PULMONARY VALVED CONDUIT IN A 6 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A HOMOGRAFT. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 14717977 ↗
• InjuryJul 2, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH AND 25 DAYS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22MM CONDUIT OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12108195 ↗
• InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, A PERMANENT PACEMAKER WAS IMPLANTED IN THE PATIENT. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 11625014 ↗
• InjuryNov 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 4 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC ROOT BIOPROSTHESIS IMPLANTED IN THE PULMONARY POSITION. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10826923 ↗
• InjuryMar 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) 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: No Information

  MAUDE report 9853596 ↗