ContegraRecalls & reported problems across all models
Medtronic, Inc. · 35 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 261
- Deaths reported
- 5
- Injuries reported
- 252
- Recalls
- 0
We found 35 models of Contegra by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 261 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2017 and Sep 30, 2026 — classified as 5 deaths, 252 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (189 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Contegra problems
Device problems
- Insufficient Device Problem Information189
- Gradient Increase29
- Adverse Event Without Identified Device or Use Problem28
- Calcified20
- Intravalvular regurgitation16
- Device Stenosis14
- Patient Device Interaction Problem11
- Inadequacy of Device Shape and/or Size5
Patient problems
- No Information93
- Pulmonary Valve Stenosis86
- Insufficient Information78
- Pulmonary Valve Insufficiency/ Regurgitation29
- Pulmonary Insufficiency15
- Calcium Deposits/Calcification14
- Pulmonary Regurgitation13
- Endocarditis11
Contegra models
35 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Contegra® 200H12pulmonic valved conduit1 death29 reports
- Contegra® 200H14pulmonic valved conduit2 deaths24 reports
- Contegra® 200H16pulmonic valved conduit18 reports
- Contegra® 200H18pulmonic valved conduit16 reports
- Contegra® 200SH22pulmonic valved conduit12 reports
- Contegra® 200H18pulmonic valved conduit12 reports
- Contegra® 200H12pulmonic valved conduit11 reports
- Contegra® 200H20pulmonic valved conduit11 reports
- Contegra® 200SH20pulmonic valved conduit10 reports
- Contegra® 200H16pulmonic valved conduit10 reports
- Contegra® 200H22pulmonic valved conduit10 reports
- Contegra® 200SH18pulmonic valved conduit9 reports
- Contegra® 200H14pulmonic valved conduit8 reports
- Contegra® 200SH22pulmonic valved conduit1 death8 reports
- Contegra® 200SH16pulmonic valved conduit7 reports
- Contegra® 200SH20pulmonic valved conduit7 reports
- Contegra® 200H20pulmonic valved conduit7 reports
- Contegra® 200H14pulmonic valved conduit6 reports
- Contegra® 200SH16pulmonic valved conduit1 death5 reports
- Contegra® 200SH18pulmonic valved conduit5 reports
- Contegra® 200H12pulmonic valved conduit4 reports
- Contegra® 200H18pulmonic valved conduit4 reports
- Contegra® 200H22pulmonic valved conduit4 reports
- Contegra® 200SH14pulmonic valved conduit3 reports
- Contegra® 200SH16pulmonic valved conduit3 reports
- Contegra® 200H16pulmonic valved conduit3 reports
- Contegra® 200SH12pulmonic valved conduit3 reports
- Contegra® 200SH14pulmonic valved conduit2 reports
- Contegra® 200SH14pulmonic valved conduit2 reports
- Contegra® 200H18pulmonic valved conduit2 reports
- Contegra® 200SH14pulmonic valved conduit2 reports
- Contegra® 200SH12pulmonic valved conduit1 report
- Contegra® 200SH20pulmonic valved conduit1 report
- Contegra® 200SH16pulmonic valved conduit1 report
- Contegra® 200SH12pulmonic valved conduit1 report
Recent Contegra adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Patient Device Interaction Problem
Medtronic received information that post implant of this 18mm pulmonary valved conduit on the same day, a Bi-Ventricular pacemaker was implanted. The reason for the Bi-Ventricular pacemaker was reported as complete heart block (CHB). No additional adverse patient effects were reported.
Patient problems: Heart Block
MAUDE report 50942975 ↗InjurySep 30, 2026Patient Device Interaction Problem
Medtronic received information that 11 days post implant of this 16mm contegra pulmonary valved conduit, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as complete heart block (CHB). No additional adverse patient effects were reported.
Patient problems: Heart Block
MAUDE report 50942944 ↗InjurySep 23, 2026Patient Device Interaction Problem
Medtronic received information that during the implant of this 18mm pulmonary valved conduit in then a 4 year old pediatric patient, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as complete heart block (CHB). No additional adverse patient effects were reported.
Patient problems: Heart Block
MAUDE report 50867050 ↗InjuryJun 2, 2026Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 20MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 8 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE PULMONARY REGURGITATION (PR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Insufficiency/ Regurgitation
MAUDE report 25360952 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 2 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVE CONDUIT IMPLANTED IN A 5 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A NEW 16MM 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 25328118 ↗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 ↗InjuryMar 24, 2026Gradient Increase; Inadequacy of Device Shape and/or Size; Device Stenosis; Intravalvular regurgitation
ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR REPLACEMENT WAS DUE TO OUTGROWTH OF THE ORIGINAL CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis
MAUDE report 24672704 ↗InjuryMar 12, 2026Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 8 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 1 YEAR OLD PEDIATRIC PATIENT, AN 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS RIGHT VENTRICULAR OUTFLOW TRACT OBSTRUCTION (RVOTO). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24586481 ↗InjuryMar 10, 2026Device Stenosis
IT WAS REPORTED THAT 7 YEARS AND 2 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVE CONDUIT IMPLANTED IN A THEN 4 YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MILD PULMONARY STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Stenosis
MAUDE report 24560994 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT 10 YEARS AND 6 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVE CONDUIT IMPLANTED IN RIGHT VENTRICLE-PULMONARY ARTERY (RV-PA) POSITION AND IMPLANTED IN A THEN 9 MONTHS OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM PULMONARY VALVE CONDUIT IN THE SAME IMPLANT POSITION. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24520315 ↗InjuryFeb 17, 2026Device Stenosis
IT WAS REPORTED THAT 7 YEARS AND 3 MONTHS POST IMPLANT OF THIS 22M PULMONARY VALVED CONDUIT, A 18MM TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE CONDUIT STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Stenosis
MAUDE report 24365515 ↗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 ↗InjuryFeb 10, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVE CONDUIT IMPLANTED IN A THEN 2-YEAR-OLD PEDIATRIC PATIENT, A 16MM PULMONARY TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24305207 ↗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 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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