| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00370-1 |
| Product Name/Description |
HeartWare HVAD System
Product Codes: 1100, 1101, 1102, 1104, 1205 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
HeartWare is providing further information to users regarding:
1. Worn Alignment Guides,
2. Internal "Double Disconnect Alarm" Battery,
3. Power Management Software Upgrade,
4. Driveline Outer Sheath Discoloration & Cracking, and
5. Snagging or Pulling of the Driveline. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
HeartWare is reiterating warnings and precautions stated in the Instructions for Use and Operators Manual to ensure the safe use of the devices. HeartWare is also notifying health care professionals of an additional warning regarding discolouration and cracking of the drive line due to exposure to UV light.
Further information can be found ont he TAG website at https://www.tga.gov.au/alert/heartware-ventricular-assist-system
This action has been closed out on the 26/10/2018. |
| Contact Information |
02 8078 6164 - HeartWare Pty Ltd |