Contegra® 200SH14 (UDI 00613994600158)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994600158), received between Sep 7, 2018 and Oct 11, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2022Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 4 MONTHS POST IMPLANT OF THIS 14 MM PULMONARY VALVED CONDUIT IN A 22 MONTH OLD PEDIA TRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22 MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS STENOSIS. IT WAS REPORTED THAT THE VALVE WAS "CALCIFIED ALONG ITS ENTIRE LENGTH". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 15581626 ↗
• InjuryJun 25, 2020Adverse 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 10 YEARS 1 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 10194481 ↗
• InjurySep 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SEVEN YEARS AND FOUR MONTHS POST IMPLANT OF THIS 14MM PULMONARY BIOPROSTHETIC VALVED CONDUIT, THE VALVE WAS EXPLANTED AND REPLACED WITH A 20MM BIOPROSTHETIC VALVED CONDUIT OF A DIFFERENT MODEL. THE CONDUIT WAS EXPLANTED FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Valve Stenosis; Unspecified Infection

  MAUDE report 7857431 ↗