Contegra® 200H12 (UDI 00643169298644)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169298644), received between Apr 11, 2017 and Jan 11, 2023 — classified as 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 7 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A 1 YEAR 4 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS CONDUIT INSUFFICIENCY. IT WAS REPORTED THAT ANEURYSMAL DILATION AND THE APPEARANCE OF A PSEUDOANEURYSM WERE NOTED AT THE DISTAL END OF THE CONDUIT, WHICH WAS FOUND TO BE LIKELY SECONDARY TO OUTFLOW OBSTRUCTION DUE TO THE PATIENTS HISTORY OF HYPOPLASTIC PULMONARY ARTERIES. IT WAS ALSO REPORTED THAT A PROXIMAL LEFT AND RIGHT PULMONARY ARTERIOPLASTY WAS PERFORMED DURING THIS PROCEDURE. LASTLY, IT WAS REPORTED THAT POSTOPERATIVE BLEEDING WAS NOTED WHICH REQUIRED THREE ROUNDS OF PLATELETS, CRYOPRECIPITATE AND TWO DOSES OF NOVOSEVEN RECOMBINANT- FACTOR VII. A POST-REPAIR INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED NO SIGNIFICANT RIGHT VENTRICLE ( RV) TO PULMONARY ARTERY (PA) CONDUIT DYSFUNCTION OR STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aneurysm; Pseudoaneurysm; Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 16137432 ↗
• InjuryOct 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR 4 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IMPLANTED IN A 2 MONTH OLD PATIENT, A TRANSCATHETER BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED DUE TO DISTAL CONDUIT STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 9234411 ↗
• InjuryOct 22, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 10 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 9221018 ↗
• InjuryApr 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE YEAR, THREE MONTHS POST IMPLANT OF THIS BIOPROSTHETIC PULMONIC VALVED CONDUIT IN A PEDIATRIC PATIENT, THIS DEVICE WAS EXPLANTED AND REPLACED. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6483124 ↗