Contegra® 200SH16 (UDI 00613994600172)Recalls & reported problems
Medtronic, Inc. · CNDT 200SH16 CONTEGRA SUPP HDE GBR1-PS · Class f · Implant
All models of Contegra (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994600172), received between Jan 10, 2019 and Oct 15, 2021 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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
Device problems
- Insufficient Device Problem Information3
Patient problems
- No Information2
- Insufficient Information1
- Pulmonary Valve Stenosis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 8 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A 3 YEAR 2 MONTH OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12642680 ↗InjuryMay 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 8 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A 21 MONTH OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Information; Pulmonary Valve Stenosis
MAUDE report 10033007 ↗InjuryJan 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 10 MONTHS POST IMPLANT OF THIS 16MM PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM VALVE OF THE SAME MODEL. THE REASON FOR REPLACEMENT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 8236666 ↗
Other pulmonic valved conduit devices
- Contegra® 200H12Medtronic, Inc. · pulmonic valved conduit1 death29 reports
- Contegra® 200H14Medtronic, Inc. · pulmonic valved conduit2 deaths24 reports
- Contegra® 200H16Medtronic, Inc. · pulmonic valved conduit18 reports
- Contegra® 200H18Medtronic, Inc. · pulmonic valved conduit16 reports
- Contegra® 200SH22Medtronic, Inc. · pulmonic valved conduit12 reports
- Contegra® 200H18Medtronic, Inc. · pulmonic valved conduit12 reports
- Contegra® 200H12Medtronic, Inc. · pulmonic valved conduit11 reports
- Contegra® 200H20Medtronic, Inc. · pulmonic valved conduit11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page