International safety notice
Urgent Field Safety Notice for ACCOLADE, ACCOLADE MRI; PROPONENT, PPOPONENT MRI; ESSENTIO, ESSENTIO MRI; VISIONIST X4; VALITUDE X4 by Boston Scientific CRM
Germany / BfArM · DEU · Sep 13, 2018
Key facts
| Title | Urgent Field Safety Notice for ACCOLADE, ACCOLADE MRI; PROPONENT, PPOPONENT MRI; ESSENTIO, ESSENTIO MRI; VISIONIST X4; VALITUDE X4 by Boston Scientific CRM |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | ACCOLADE, ACCOLADE MRI; PROPONENT, PPOPONENT MRI; ESSENTIO, ESSENTIO MRI; VISIONIST X4; VALITUDE X4 |
| Manufacturer | Boston Scientific CRM |
| Models | 907-925, 92289212-FA, 0.0003, GUIDELINES1 |
| Date | Sep 13, 2018 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
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