International safety notice
Sistema de Colocación Edwards SAPIEN 3 Ultra, modelos 9630TF20, 9630TF23, 9630TF26, 9630TF29.
Spain / AEMPS · ESP · Jul 26, 2019
Key facts
| Title | Sistema de Colocación Edwards SAPIEN 3 Ultra, modelos 9630TF20, 9630TF23, 9630TF26, 9630TF29. |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Sistema de Colocación Edwards SAPIEN 3 Ultra, modelos 9630TF20, 9630TF23, 9630TF26, 9630TF29. |
| Manufacturer | Edwards Lifesciences LLC, Estados Unidos. |
| Models | 91.822.52.89, 2019-409, 46980, 9630TF26, 9630TF20, 53577, FCA-141, 9630TF23, 28022, 9630TF29 |
| Event type | Safety Notice |
| Date | Jul 26, 2019 |
At a glance
- No Recall
- Yes Field safety notice
- 10–99 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