International safety notice
Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
Germany / BfArM · DEU · May 15, 2017
Key facts
| Title | Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc. |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | HeartWare Ventricular Assist System |
| Manufacturer | Heartware, Inc. |
| Models | ASY00116, APR2015B.1, ASY00281 |
| Date | May 15, 2017 |
| 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