International safety notice
St. Jude Medical
United Kingdom / MHRA · GBR · Dec 1, 2015
Key facts
| Title | St. Jude Medical |
|---|---|
| Regulator | United Kingdom / MHRA |
| Country | GBR |
| Brand | All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ implantable cardioverter defibrillators (ICDs) and Assurity™ and Allure™ pacemakers when used with Merlin@home™ RF Remote Monitoring Transmitter Model EX1150. |
| Manufacturer | St. Jude Medical |
| Event type | Safety Notice |
| Action type | Field safety notice |
| Date | Dec 1, 2015 |
| Regulator page | gov.uk |
At a glance
- No Recall
- Yes 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