Contegra® 200SH18 (UDI 00643169616868)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169616868), received between Aug 23, 2017 and Mar 24, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Gradient Increase” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Gradient Increase; Inadequacy of Device Shape and/or Size; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS DUE TO OUTGROWTH OF THE ORIGINAL CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24672704 ↗
• InjuryNov 13, 2024Calcified; Gradient Increase; Intravalvular regurgitation; Calcified; Gradient Increase; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, THE PATIENT PRESENTED WITH "FREE PULMONARY REGURGITATION AND A GRADIENT OF 29MMHG DUE TO WHAT LOOKED TO BE A CALCIFIED FROZEN LEAFLET". IT WAS REPORTED THAT A BALLOON VALVULOPLASTY WAS PERFORMED USING HIGH PRESSURE ATLAS BALLOONS. TWO STENTS WERE PLACED THEN POST DILATED WITH A 20MM ATLAS, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 20676307 ↗
• InjuryMay 5, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT, 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 11776158 ↗
• InjuryNov 30, 2017Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 3 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 VALVED CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 7070570 ↗
• InjuryAug 23, 2017Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 DAYS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, THE DEVICE WAS REPLACED DUE TO UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Congenital Defect/Deformity; Death; No Information

  MAUDE report 6814600 ↗