Contegra® 200H14 (UDI 00643169616905)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00643169616905), received between Jun 19, 2017 and Mar 25, 2026 — classified as 2 deaths, 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (17 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 1 YEARS AND 8 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVE CONDUIT IMPLANTED IN A THEN 8 MONTHS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM PULMONARY VALVE CONDUIT OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24687214 ↗
• MalfunctionJan 13, 2026Gradient Increase; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 3 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 6-MONTH-OLD PEDIATRIC PATIENT, THE PATIENT WAS SEEN BY CHOP CARDIOLOGIST FOR CLINICAL FOLLOW UP. ECHO DEMONSTRATED MODERATE CONDUIT REGURGITATION. THIS WAS AN INCREASE FROM MILD REGURGITATION AT LAST VISIT [(B)(6) 2025 ECHO]. THE ECHOCARDIOGRAM SHOWS AN INCREASE IN THE CONDUIT GRADIENT FROM 31 MMHG ON PRIOR STUDY TO ABOUT 50 MMHG. THE ARCH IS PATENT AND THERE IS GOOD BIVENTRICULAR FUNCTION. THE CARDIOLOGIST NOTES THE PATIENT IS DOING WELL AND WILL FOLLOW THE ECHO FINDINGS IN 4-6 MONTHS. DR. GAYNOR [CHOP PI] SAYS THIS COULD BE POSSIBLY RELATED TO THE CONDUIT, AND NOT UNEXPECTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 24052212 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 YEAR AND 5 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 1 AND A HALF YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 16MM PULMONARY VALVED CONDUIT OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23751622 ↗
• InjuryFeb 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 2 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 16MM CONDUIT OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21471230 ↗
• InjuryDec 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 6 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20843826 ↗
• InjuryAug 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 DAYS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 1 YEAR OLD PEDIATRIC PATIENT, IT WAS REPORTED THAT THE PATIENT HAD ENDOCARDITIS. A KARIUS TEST WAS PERFORMED AND WAS POSITIVE FOR STAPHYLOCOCCUS EPIDERMIDIS AND AGGREGETIBACTER APHROPHILUS. IT WAS ALSO REPORTED THAT THE PATIENT HAD IRRITABILITY, A LOW GRADE FEVER AND TACHYPNEA. AN ECHOCARDIOGRAM (ECHO) DISCOVERED VEGETATION ON THE PULMONARY VALVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ANTIBIOTICS WERE PRESCRIBED. IT WAS ALSO REPORTED THAT THE DEVICE WAS PREPPED FOR IMPLANTATION ACCORDING TO THE CONDUITS INSTRUCTION FOR USE (IFU). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Fever; Increased Respiratory Rate; Irritability

  MAUDE report 19916033 ↗
• InjuryMar 26, 2024Patient Device Interaction Problem; Device Stenosis; Patient Device Interaction Problem; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 1 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS AND A THROMBUS ON THE CONDUIT. MEDICATION WAS GIVEN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 18983240 ↗
• InjuryMar 14, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT, AN ECHOCARDIOGRAM INDICATED THE PRESENCE OF A THROMBUS ON ONE OF THE CONDUIT LEAFLETS. DIMINISHED RIGHT VENTRICULAR FUNCTION, A FENESTRATED ATRIAL SEPTAL DEFECT WITH LEFT TO RIGHT SHUNTING AND A HYPOPLASTIC LEFT PULMONARY ARTERY WERE ALSO NOTED ON THE ECHOCARDIOGRAM. ANTICOAGULANT MEDICATION WAS INITIATED. IT WAS STATED THAT A HYPERCOAGULABLE WORK UP WAS SENT, WHICH WAS FOUND TO BE NEGATIVE. IT WAS ADDITIONALLY REPORTED THAT 12 DAYS LATER, THE ECHO DENSITY WAS NO LONGER OBSERVED. THE MEDICATION WAS DISCONTINUED. IT WAS MENTIONED THAT THE PHYSICIAN THOUGHT THIS EVENT WAS POSSIBLY RELATED TO THE CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18908323 ↗
• InjuryNov 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 6 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 16MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18091106 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 1 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16853398 ↗
• InjuryFeb 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 1 MONTH POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A 7 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16335869 ↗
• InjuryDec 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT, AN ECHOCARDIOGRAM SHOWED SIGNIFICANT BILATERAL BRANCH PULMONARY STENOSIS WITH ASSOCIATED RIGHT VENTRICULAR HYPERTENSION.  IT WAS STATED THAT THERE WAS DISCRETE STENOSIS OF BOTH THE RIGHT AND LEFT PULMONARY ARTERIES JUST BEYOND THE CONDUIT INSERTION. IT WAS MENTIONED THAT THE PRESSURE IN BOTH THE RIGHT PULMONARY ARTERY AND THE LEFT PULMONARY ARTERY WAS 14MMHG AND 8MMHG RESPECTIVELY WITH A MEAN PRESSURE OF 11 MMHG. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CATHETERIZATION WITH A SERIAL BALLOON DILATION OF BOTH THE PROXIMAL RIGHT AND LEFT PULMONARY ARTERIES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 16008092 ↗
• InjuryNov 19, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 6 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A 10 MONTHS, 21 DAYS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15829797 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED TO BE DILATION OF THE CONDUIT DUE TO A DISTAL OBSTRUCTION. IT WAS MENTIONED THAT THERE WAS DENSE FIBROUS REACTION AT THE PULMONARY ARTERY CONFLUENCE. IT WAS STATED THAT THIS WAS FULLY DISSECTED. IT WAS NOTED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM PERFORMED AFTER REPLACEMENT OF THE CONDUIT SHOWED A GRADIENT OF APPROXIMATELY 20 TO 25MMHG IN THE PROXIMAL RIGHT PULMONARY ARTERY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15317578 ↗
• InjuryApr 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT, IT WAS EXPLANTED AND REPLACED WITH A 16MM VALVE OF THE SAME MODEL DUE TO A RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) ANEURYSM. IT WAS REPORTED "THE ANEURYSM WAS A TRUE ANEURYSM WITH NO SUTURE LINE RUPTURE." RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) STENOSIS WAS REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aneurysm; Pulmonary Valve Stenosis

  MAUDE report 14255070 ↗
• InjuryJan 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 2 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 19MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13393965 ↗
• InjuryJan 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 8 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS AND MODERATE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 13169902 ↗
• InjurySep 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 1 MONTH POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 16MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 12518772 ↗
• InjuryMar 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS AND 3 WEEKS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 9866371 ↗
• InjuryMar 16, 2020Calcified; Biocompatibility; Material Deformation; Insufficient Device Problem Information; Calcified; Biocompatibility; Material Deformation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A (B)(6) OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Blood Loss; Fibrosis; No Information; Pulmonary Valve Stenosis

  MAUDE report 9835814 ↗
• InjuryDec 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS 3 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN THIS PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH AN 18MM PULMONARY VALVED CONDUIT. IT WAS REPORTED THAT THERE WAS STENOSIS ON THE LEFT ATRIUM, ESSENTIALLY SUBDIVIDING THE COMMON PULMONARY VENOUS CHAMBER OF THE LEFT ATRIUM FROM THE MITRAL BELOW. THIS 18MM CONDUIT WAS USED VENTRICLE TO PULMONARY ARTERY. POST SURGERY AND OFF BYPASS, THE PATIENT HAD SURGICAL BLEEDING AND BECAME HYPOTENSIVE WHICH REQUIRED BLOOD VOLUME ADMINISTRATION. ADDITIONALLY DURING THE REPAIR OF THE SURGICAL BLEEDING SITE, THE PATIENT BECAME PROFOUNDLY HYPOTENSIVE WITH THE HALLMARKS OF WHAT APPEARED TO BE SEVERE PULMONARY HYPERTENSIVE CRISIS. ULTIMATELY THE PATIENT WAS SUCCESSFULLY RESUSCITATED WITH EPINEPHRINE AND OTHER MEDICAL MEASURES AND EVENTUALLY STABILIZED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 9489526 ↗
• DeathDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT OF THIS BIOPROSTHETIC PULMONARY VALVED CONDUIT, THE PATIENT BECAME HYPOTENSIVE. THE PATIENT EXPERIENCED CARDIAC ARREST, AND RESUSCITATION MEASURES WERE PERFORMED. THE PATIENT WAS PLACED ON VENOUS-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO), AND UNDERWENT MEDIASTINAL EXPLORATION DUE TO BLEEDING. BLEEDING FROM THE SUPERIOR AND INFERIOR VENA CAVA WAS NOTED. THIS WAS REPORTED TO BE A RESULT OF SUTURES THAT TORE THROUGH THE SURROUNDING TISSUE DURING THE RESUSCITATION MEASURES. THE VESSEL DAMAGE WAS REPAIRED WITH SUTURES, AND THE PATIENT WAS RETURNED TO THE INTENSIVE CARE UNIT IN CRITICAL BUT STABLE CONDITION. THERE WAS NO ALLEGATION THAT THE CONTEGRA CONDUIT OR ITS FUNCTION CONTRIBUTED TO THE CARDIAC ARREST. SIX DAYS POST IMPLANT OF THE CONDUIT, CARDIAC CATHERIZATION SHOWED CONDUIT THROMBOSIS. SEVEN DAYS POST IMPLANT IT WAS EXPLANTED AND REPLACED WITH ANOTHER CONDUIT OF THE SAME SIZE AND MODEL. IT WAS REPORTED THAT THE CONDUIT WAS "COMPLETELY THROMBOSED". THROMBUS WAS ALSO REMOVED FROM THE RIGHT VENTRICLE AND MAIN PULMONARY ARTERY. THE PATIENT REMAINED ON ECMO SUPPORT AFTER COMPLETION OF THE CONDUIT REPLACEMENT. TWO DAYS

  Patient problems: Death; Neurological Deficit/Dysfunction

  MAUDE report 9426144 ↗
• InjuryMay 1, 2018Adverse 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 DURING THE IMPLANT OF THIS 14MM BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 12MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.

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

  MAUDE report 7476188 ↗
• DeathJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 14 MM BIOPROSTHETIC VALVED CONDUIT, THE PATIENT ARRESTED AT HOME DUE TO ONGOING ISSUES WITH RESPIRATORY SUPPORT AND PULMONARY EDEMA/HEMORRHAGE. SUBSEQUENTLY, THE PATIENT DIED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Pulmonary Edema

  MAUDE report 6651842 ↗