| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01528-1 |
| Product Name/Description |
SynCardia Freedom Driver System (a component of the SynCardia temporary Total Artificial Heart System)
Product Code: SYN-595000-001
Supplied through Clinical Trial and SAS Category A |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/12/2017 |
| Responsible Entity |
|
| Reason/Issue |
SynCardia has updated the Freedom Driver System manuals and labelling to strengthen existing labelling content with regard to Freedom Driver drops, rough handling and exposure to liquid/debris.
The Freedom Driver System manuals have been updated as follows:
- Advising patients to switch from their primary Freedom Driver to their backup Freedom Driver in the event their Freedom Driver is dropped, subjected to rough handling or exposed to liquid/debris.
- Adding more detailed information regarding the definition of rough handling.
- Advising hospital clinicians, patients and their caregivers to clean the Freedom Driver and drivelines ONLY with a cloth lightly dampened with water.
- Advising hospital clinicians to refresh patient and caregiver training at every clinic visit. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is providing users with updated manuals.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG |
| Contact Information |
02 9972 8222 - Device Technologies |