Contegra® 200SH12 (UDI 00643169298583)Recalls & reported problems
Medtronic, Inc. · CNDT 200SH12 CONTEGRA GBR1 HDE TEMP IND · Class f · Implant
Data updated Oct 13, 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 00643169298583), received between Feb 8, 2019 and Feb 8, 2019 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- 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.
InjuryFeb 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 8 MONTHS POST IMPLANT OF THIS PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, THE BRANCHES OF THE CONDUIT WERE FOUND TO BE "FLOW-LIMITING". AT THIS TIME, ANGIOPLASTY WAS PERFORMED ON TWO COLLATERAL VESSELS DUE TO PROXIMAL STENOSIS. 1 YEAR AND 9 MONTHS POST IMPLANT, STABLE, SEVERE, DILATATION OF THE HOOD OF THE CONDUIT WAS IDENTIFIED. NO INTERVENTIONS WERE PERFORMED ON THE CONDUIT. ULTIMATELY, 2 YEARS AND 9 MONTHS POST IMPLANT, THE 12MM CONDUIT WAS EXPLANTED AND REPLACED WITH A 16MM CONDUIT OF THE SAME MODEL. THE EXPLANTED CONDUIT HAD AN INTERNAL DIAMETER OF 9MM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Stenosis
MAUDE report 8323762 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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