Contegra® 200SH20 (UDI 00643169298545)Recalls & reported problems
Medtronic, Inc. · CNDT 200SH20 CONTEGRA GBR3 HDE TEMP IND · Class f · Implant
All models of Contegra (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169298545), received between Aug 18, 2017 and Aug 18, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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 Information1
- Structural Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
- Pulmonary Insufficiency1
- Pulmonary Valve Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2017Structural Problem; Insufficient Device Problem Information; Structural Problem; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 6 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT, THE PATIENT HAD THE VALVED CONDUIT REPLACED DUE TO AN UNKNOWN FAILURE MODE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. ATTEMPTS TO OBTAIN FURTHER INFORMATION WERE NOT SUCCESSFUL.
Patient problems: No Known Impact Or Consequence To Patient; Pulmonary Insufficiency; Pulmonary Valve Stenosis
MAUDE report 6804051 ↗
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.
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