Contegra® 200SH14 (UDI 00643169298576)Recalls & reported problems
Medtronic, Inc. · CNDT 200SH14 CONTEGRA GBR1 HDE TEMP IND · Class f · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169298576), received between Oct 28, 2019 and Dec 10, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Insufficient Information1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 8 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 10 MONTH AND 12 DAY OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 29MM BIOPROSTHETIC VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS DEGENERATION OF THE PROTHESIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 20892523 ↗InjuryOct 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 3 MONTHS POST IMPLANT OF THIS 14MM PULMONARY VALVED CONDUIT IN A PEDIATRIC PATIENT, THE CONDUIT WAS EXPLANTED AND REPLACED WITH AN 18MM 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 9245080 ↗
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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