Contegra® 200H12 (UDI 00643169616899)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00643169616899), received between Apr 19, 2017 and Feb 17, 2026 — classified as 1 death, 28 injuries.

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. 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 6 YEARS AND 9 MONTHS POST IMPLANT 12MM PULMONAR6Y VALVE CONDUIT IMPLANTED IN A THEN 3-MONTH-OLD PEDIATRIC PATIENT, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE PULMONARY CENTRAL REGURGITATION. SUBSEQUENTLY ON (B)(6) 2026 THE PATIENT SUCCESSFULLY HAD A 18MM PULMONARY TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 24361985 ↗
• InjuryDec 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS 12MM 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 23681280 ↗
• InjuryApr 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 7 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 5-MONTH-OLD PEDIATRIC PATIENT, IT WAS REPORTED THAT AN ECHOCARDIOGRAM DISCOVERED FOCAL NARROWING OF THE RIGHT PULMONARY ARTERY (RPA). SUBSEQUENTLY, 3 MONTHS LATER, THE PATIENT UNDERWENT A CARDIAC CATHETERIZATION AND STENT ANGIOPLASTY OF THE RPA. THE REASON FOR THE STENT ANGIOPLASTY WAS REPORTED AS FOCAL NARROWING AND SEVERE STENOSIS OF THE PROXIMAL RPA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21901192 ↗
• InjuryMar 5, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 12MM CONTEGRA VALVED CONDUIT, PRE-OPERATIVE DIAGNOSIS NOTED HEMOPERICARDIUM AND A COMPUTED TOMOGRAPHY (CT) PERFORMED NOTED ¿CLOT BURDEN AROUND THE HEART¿. IT WAS STATED THAT THE PATIENT WAS BROUGHT TO THE OPERATING ROOM (OR) AND A MEDIASTINAL WASHOUT WAS PERFORMED. IT WAS STATED THAT THROMBUS WAS NOTED THROUGHOUT THE MEDIASTINUM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21527160 ↗
• InjuryJan 21, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REGURGITATION WAS LIKELY EXACERBATED BY PROXIMAL BRANCH PULMONARY ARTERY STENOSIS. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 21196005 ↗
• InjuryJan 16, 2025Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT A FOLLOW-UP ECHOCARDIOGRAM DISCOVERED SEVERE PULMONARY REGURGITATION OF THE CONDUIT. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 21172487 ↗
• InjuryAug 6, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 15 DAYS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 6 MONTH OLD PEDIATRIC PATIENT, IT WAS REPORTED THAT THE PATIENT HAD ENDOCARDITIS AND WAS FEBRILE WITH ELEVATED WHITE BLOOD CELLS (WBC) AND INFLAMMATORY MARKERS. THE PATIENT REMAINS HOSPITALIZED FROM IMPLANT SURGERY. AN ECHOCARDIOGRAM (ECHO) DISCOVERED VEGETATION ON THE CONDUIT. ANTIBIOTICS WERE PRESCRIBED AND THE PATIENT IS EXPECTED TO CONTINUE THE ANTIBIOTICS FOR SIX WEEKS. IT WAS ALSO REPORTED THAT BLOOD CULTURES WERE NEGATIVE FOR ENDOCARDITIS, BUT A POLYMERASE CHAIN REACTION (PCR) TEST REVEALED A COMMON ORAL PATHOGEN. IT WAS ALSO NOTED THAT THE CONDUIT WAS PREPPED FOR IMPLANT PER THE INSTRUCTIONS FOR USE (IFU) OF THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Fever; High White Blood Cell Count

  MAUDE report 19915985 ↗
• InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 DAYS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 7 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 12MM 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 19584332 ↗
• InjuryApr 12, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 6 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 4 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT THE REASON FOR REPLACEMENT WAS PULMONARY INSUFFICIENCY AND PULMONARY STENOSIS. IT WAS NOTED THAT MILD PULMONARY INSUFFICIENCY WAS OBSERVED ON A TRANSTHORACIC ECHOCARDIOGRAM (TTE) TWO DAYS POST REPLACEMENT PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19097031 ↗
• InjuryFeb 2, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 6 MONTH OLD PEDIATRIC PATIENT, IT WAS REPORTED THAT A FOLLOW-UP ECHOCARDIOGRAM (ECHO) DISCOVERED "WIDE OPEN" PULMONARY REGURGITATION. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 18631948 ↗
• InjuryMay 15, 2023Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 2 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A THEN 6 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC HOMOGRAFT. THE REASON FOR REPLACEMENT WAS REPORTED AS THE CONDUIT HAD BECOME CALCIFIED AND DEVELOPED AN OBSTRUCTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16935536 ↗
• InjuryNov 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 7 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN THIS 7 DAY OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM PULMONARY VALVED CONDUIT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12836894 ↗
• InjuryJun 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 10 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A 3 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH AN 18MM 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 12083987 ↗
• InjuryJun 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION 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: Insufficient Information

  MAUDE report 12025872 ↗
• InjuryApr 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 7 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN AN 8 MONTH OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 14MM CONDUIT. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11656688 ↗
• InjuryAug 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 MONTHS AND 25 DAYS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A (B)(6)-DAY-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: No Information; Pulmonary Insufficiency; Pulmonary Valve Stenosis

  MAUDE report 10358197 ↗
• InjuryJul 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A (B)(6) DAY 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: No Information

  MAUDE report 10320096 ↗
• InjuryJul 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 10 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A (B)(6)-MONTH-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM PULMONARY VALVED CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10257623 ↗
• InjuryMar 18, 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 5 MONTHS AND 9 DAYS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A (B)(6) OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 16MM PULMONARY VALVED CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Information

  MAUDE report 9848689 ↗
• InjuryAug 8, 2019Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A (B)(6)-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A PULMONARY VALVED CONDUIT OF THE SAME SIZE. THE REASON FOR REPLACEMENT WAS CONDUIT OBSTRUCTION AND CONDUIT STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 8873533 ↗
• InjuryJul 29, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 9 DAYS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A (B)(6)-OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A ¿VALVE OF A DIFFERENT LENGTH¿. THE SURGEON REPORTED THE INITIAL IMPLANT WAS TOO LONG FOR THE PATIENT AND CAUSED THE STERNUM TO PRESS ON THE PULMONARY ARTERY. AS THE STERNUM HAD A DELAYED CLOSURE, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A HOMOGRAFT. THE SURGEON ALSO REPORTED THAT THE PATIENT IS DOING WELL AFTER SURGERY WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 8839253 ↗
• InjuryMar 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT IN A (B)(6) OLD PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH A 20MM VALVED CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8400673 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE YEAR POST IMPLANT OF THIS 12MM BIOPROSTHETIC PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 18MM CONDUIT OF THE SAME MODEL AS PART OF A NORWOOD PROCEDURE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8329893 ↗
• DeathJan 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 24 HOURS POST IMPLANT OF THIS 12MM PULMONARY VALVED CONDUIT USED IN THIS PEDIATRIC PATIENT IN THE MITRAL POSITION THERE WERE POSITIVE BLOOD CULTURES FOR SEPSIS. THE CAUSE OF SEPSIS WAS UNKNOWN AS THE PATIENT WAS VERY SICK WITH AN OPEN CHEST. THE PULMONARY CONDUIT WAS IMPLANTED INSIDE OF A 14MM DACRON TUBE DUE TO SEVERE MITRAL REGURGITATION. THREE DAYS POST IMPLANT THE PATIENT EXPERIENCED COMPLETE ATRIO-VENTRICULAR (AV) BLOCK, PERSISTENT HYPOTENSION AND MODERATE AORTIC INSUFFICIENCY REQUIRING ESCALATION IN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) FLOWS. THIS CASE WAS FURTHER COMPLICATED BY RIGHT SIDED SEIZURE ACTIVITY. THERE WAS INCREASINGLY ELEVATED LACTATES AND PROGRESSIVE ACIDOSIS. THREE DAYS LATER, AFTER DISCUSSING WITH THE PATIENT'S FAMILY REGARDING THE GRIM SHORT AND LONG TERM PROGNOSIS, THEY REQUESTED TO DISCONTINUE ALL HEROIC LIFE SUPPORT MEASURES. THE PATIENT WAS DISCONTINUED FROM EXTRACORPOREAL AND VENTILATOR SUPPORT AND PASSED AWAY IMMEDIATELY THEREAFTER. NO AUTOPSY WAS PERFORMED AND THE DEVICE REMAINS IN THE PATIENT AND WILL NOT BE RETURNED.

  Patient problems: Aortic Insufficiency; Complete Heart Block; Death; Low Blood Pressure/ Hypotension; Sepsis

  MAUDE report 8260606 ↗
• InjuryAug 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT PULMONARY BIOPROSTHETIC VALVED CONDUIT WAS IMPLANTED IN A 9 MONTH OLD PATIENT. ONE YEAR 2 MONTH POST IMPLANT, 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: No Information; Pulmonary Regurgitation; Tricuspid Regurgitation

  MAUDE report 7805383 ↗