Contegra® 200SH16 (UDI 00643169298569)Recalls & reported problems
Medtronic, Inc. · CNDT 200SH16 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 00643169298569), received between Jul 6, 2020 and Jul 6, 2020 — 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
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 6 MONTHS POST IMPLANT OF THIS 16 MM PULMONARY CONDUIT VALVED IN A (B)(6)-MONTH-OLD PEDIATRIC PATIENT, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE DEPLOYED TO 22MM. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Information
MAUDE report 10237095 ↗
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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