Contegra® 200SH18 (UDI 00613994600189)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994600189), received between Jul 10, 2017 and May 26, 2020 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF A 18MM BIOPROSTHETIC PULMONARY VALVED CONDUIT, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER IMPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 10089810 ↗
• InjuryOct 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 8 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN THIS PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A 16MM TRANSCATHETER PULMONIC VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9187994 ↗
• InjuryAug 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 8 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER VALVE DUE TO SEVERE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Insufficiency

  MAUDE report 8887418 ↗
• InjuryNov 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 10 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE PHYSICIAN REPORTED THE VALVE WAS STENOTIC AND HEAVILY CALCIFIED. DURING THE REPLACEMENT PROCEDURE, TEMPORARY RHYTHM DISTURBANCES RESULTED FROM NO CARDIAC OUTPUT WHEN THE BALLOON WAS UP AND A STENT WAS PLACED IN THE CONDUIT TO HELP PREVENT RUPTURE. NO ADDITIONAL TREATMENT OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Non specific EKG/ECG Changes; Stenosis

  MAUDE report 8085240 ↗
• InjuryFeb 15, 2018Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 5 MONTHS POST IMPLANT OF THIS 18 MM BIOPROSTHETIC PULMONARY VALVED CONDUIT, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH AN 18 MM TRANSCATHETER PULMONARY VALVE (TPV) FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Pulmonary Regurgitation

  MAUDE report 7272664 ↗
• InjuryDec 21, 2017Calcified; Gradient Increase; Calcified; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS 8 MONTHS POST IMPLANT OF THIS PULMONARY BIOPROSTHETIC VALVED CONDUIT IN THIS PEDIATRIC PATIENT, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY VALVE (TPV) DUE TO SEVERE SYMPTOMATIC CONDUIT STENOSIS. THE VALVE APPEARED HEAVILY CALCIFIED WITH SEVERE STENOSIS ¿ PEAK GRADIENT OF 90 MM HG BY ECHOCARDIOGRAM. BY CATHETER IT WAS NOTED TO BE 50 MM HG GRADIENT ACROSS THE CONDUIT WITH AN RV PRESSURE OF 70 MM HG (80% SYSTEMIC). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Pulmonary Valve Stenosis

  MAUDE report 7138013 ↗
• InjuryNov 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 11 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7003139 ↗
• InjuryOct 10, 2017Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS 1 MONTH POST IMPLANT OF THIS PULMONARY BIOPROSTHETIC VALVED CONDUIT IN A PEDIATRIC PATIENT, THE DEVICE WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY VALVE (TPV) FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; No Information; Pulmonary Valve Stenosis

  MAUDE report 6936753 ↗
• InjuryJul 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FIVE YEARS AND THREE MONTHS POST IMPLANT OF THIS PULMONARY BIOPROSTHETIC VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6699992 ↗