| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00313-1 |
| Product Name/Description |
IntraClude Intra-aortic Occlusion Device
Model Number: ICF100
This product has been supplied under SAS |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/04/2018 |
| Responsible Entity |
|
| Reason/Issue |
Edwards Lifesciences has identified a potential safety risk, which may occur during the use of the IntraClude intra-aortic occlusion device (ICF100). Edwards Lifesciences has received a limited number of reports (11 reports since December 2017, which is a rate of approximately 2%) regarding inflation fluid leaking out the distal open end of the strain relief. When present, this leak can be identified through normal monitoring of balloon pressure. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Edwards Lifesciences is advising users to maintain close vigilance of balloon pressure during a procedure in order to identify when additional volume is needed to maintain adequate occlusion. Consider having backup equipment available, such as aortic cross-clamps or additional IntraClude devices.
Product return is not required at this time. Currently, unaffected product is not available.
This action has been closed out on 15/11/2018 |
| Contact Information |
1800 222 601 - Customer Service Support |