International safety notice
Urgent Field Safety Notice for EVOLUT PRO PLUS, EVOLUT FX, EVOLUT FX PLUS by Medtronic CoreValve, LLC
Germany / BfArM · DEU · Mar 19, 2025
Key facts
| Title | Urgent Field Safety Notice for EVOLUT PRO PLUS, EVOLUT FX, EVOLUT FX PLUS by Medtronic CoreValve, LLC |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | EVOLUT PRO PLUS, EVOLUT FX, EVOLUT FX PLUS |
| Manufacturer | Medtronic CoreValve, LLC |
| Models | EVFXPLUS-29, 02159, 00763000655419, EVPROPLUS-26, 00763000211134, 8149-0, 00763000920432, 00763000211080, 00763000655433, US-MF-000019985, 00763000211059, 00763000370626 and 33 more |
| Date | Mar 19, 2025 |
| 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