International safety notice
Urgent Field Safety Notice for Trifecta Valve, Trifecta GT Valve by S.. Jude Medical, Costa Rica Ltd. (CS)
Germany / BfArM · DEU · Jul 31, 2023
Key facts
| Title | Urgent Field Safety Notice for Trifecta Valve, Trifecta GT Valve by S.. Jude Medical, Costa Rica Ltd. (CS) |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Trifecta Valve, Trifecta GT Valve |
| Manufacturer | S.. Jude Medical, Costa Rica Ltd. (CS) |
| Models | 1198-1205, N=233, N=258, NCT03016169, PERFORMANCE.3-4, ABBOTT_COMMUNICATION_-_TRIFECTA_VALVE_-_FINAL_FEB_2023_-_INTERNATIONAL_ENGLISH_SIGNED_01.PDF, IVAC086, 4-YEAR, 1-YEAR, N=362, TFGT-29A, 879-888 and 53 more |
| Date | Jul 31, 2023 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1