Contegra® 200SH14 (UDI 00613994600141)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994600141), received between Oct 19, 2020 and Nov 14, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Calcified” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 11MM PULMONARY VALVED CONDUIT IN A 10 MONTH OLD PEDIA TRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 16MM BIOPROSTHETIC VALVE CONDUIT. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15788081 ↗
• InjuryOct 19, 2020Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 5 MONTHS POST IMPLANT OF THIS 14 MM PULMONARY VALVED CONDUIT IN A (B)(6) OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18 MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS AND MILD PULMONARY REGURGITATION. IT WAS ALSO REPORTED THAT THE CONDUIT WAS CALCIFIED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Pulmonary Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 10700496 ↗