Contegra® 200H18 (UDI 00643169298613)Recalls & reported problems
Medtronic, Inc. · CNDT 200H18 CONTEGRA GBR3 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 00643169298613), received between Apr 22, 2020 and Jun 28, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Stenosis” (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.
Reports received per month
Most reported problems
Device problems
- Device Stenosis1
- Insufficient Device Problem Information1
- Intravalvular regurgitation1
Patient problems
- No Information1
- Pulmonary Valve Insufficiency/ Regurgitation1
- Pulmonary Valve Stenosis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation
MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 2 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IMPLANTED IN A THEN 4 YEAR OLD PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 22MM CONDUIT OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS PULMONARY STENOSIS AND PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pulmonary Valve Insufficiency/ Regurgitation; Pulmonary Valve Stenosis
MAUDE report 19633494 ↗InjuryApr 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 3 MONTHS POST IMPLANT OF THIS 18MM PULMONARY VALVED CONDUIT IN A (B)(6) PEDIATRIC PATIENT, IT WAS EXPLANTED AND REPLACED WITH A 20MM PULMONARY 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 9985493 ↗
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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