Contegra® 200SH22 (UDI 00643169616882)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169616882), received between Mar 12, 2020 and Feb 17, 2026 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Device Stenosis

  IT WAS REPORTED THAT 7 YEARS AND 3 MONTHS POST IMPLANT OF THIS 22M PULMONARY VALVED CONDUIT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE CONDUIT STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 24365515 ↗
• InjuryFeb 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 6 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 6 YEAR OLD PEDIATRIC PATIENT, A 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 18788311 ↗
• InjuryMay 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 2 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 11 YEARS OLD PEDIATRIC PATIENT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS AND SEVERE PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 16911673 ↗
• InjuryFeb 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 4 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 6 YEAR OLD PEDIATRIC PATIENT, A 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 16335648 ↗
• InjuryJul 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 12 MONTHS POST IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT IN A 11 YEAR 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 15109457 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DATE THAT THIS 22MM PULMONARY VALVED CONDUIT WAS IMPLANTED, A BIVENTRICULAR DEFIBRILLATOR WAS IMPLANTED DUE TO COMPLETE HEART BLOCK AND A HISTORY OF SPONTANEOUS SUSTAINED VENTRICULAR TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block; Tachycardia

  MAUDE report 13601847 ↗
• DeathMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION OF TIME FOLLOWING THE IMPLANT OF THIS 22MM PULMONARY VALVED CONDUIT, IMPLANTED IN AN 18 YEAR OLD PEDIATRIC PATIENT, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME.

  Patient problems: Death

  MAUDE report 9825785 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 22MM PULMONARY VALVED CONDUIT IMPLANTED IN AN (B)(6) YEAR OLD PEDIATRIC PATIENT, WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. ONE DAY LATER ANOTHER 22MM PULMONARY VALVED CONDUIT WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9825564 ↗