Contegra® 200SH16 (UDI 00643169616851)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169616851), received between Sep 29, 2017 and Mar 12, 2026 — classified as 1 death, 4 injuries.

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

• InjuryMar 12, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 8 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 1 YEAR OLD PEDIATRIC PATIENT, AN 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS RIGHT VENTRICULAR OUTFLOW TRACT OBSTRUCTION (RVOTO). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24586481 ↗
• InjuryOct 30, 2024Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 20 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS OF THE CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pulmonary Valve Stenosis

  MAUDE report 20571377 ↗
• InjuryJul 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 9 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 17388036 ↗
• DeathSep 11, 2018Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS PULMONARY BIOPROSTHETIC VALVED CONDUIT, THE CONDUIT WAS EXPLANTED DUE TO A POSSIBLE FUNGAL INFECTION. AN UNKNOWN DURATION POST EXPLANT THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT RECEIVED. THERE WAS NO EVIDENCE TO SUGGEST THAT THE CONDUIT OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Death; Endocarditis

  MAUDE report 7865153 ↗
• InjurySep 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 6905980 ↗