| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-01098-1 |
| Product Name/Description |
Cordis OPTEASE Retrievable Vena Cava Filter and OPTEASE Retrieval Catheter
OPTEASE Retrievable Vena Cava Filter
Catalog Numbers: 466F210AF, 466F210AJ, 466F210BJ
OPTEASE Retrieval Catheter
Catalog Number:466C210F
ARTG 186230
(Cordis Australia Pty Ltd - OptEase Retrievable Vena Cava Filter - Vena cava filter, optional)
ARTG 153901
(Cordis Australia Pty Ltd - Cordis OptEase retrieval catheter - Catheter, snare) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/01/2024 |
| Responsible Entity |
|
| Reason/Issue |
This action is being conducted to inform end users of clarifications to the previously defined timeframe the OPTEASE Retrievable Vena Cava Filter device is implanted before retrieval. Therefore, Cordis has updated the Warning statement in accordance with regulatory requirements as follows:
"The OPTEASE Retrievable Filter has not been studied for long term implantation and must be retrieved within 12 days after placement."
The statement below was removed from the device description for the OPTEASE Retrieval Catheter in accordance with the updates made to the Warning statement in the IFU for the Cordis OPTEASE Retrievable Vena Cava Filter and OPTEASE Retrieval Catheter:
“The OPTEASE Retrievable Filter can be retrieved within a specified period after implantation (refer to the OPTEASE Retrievable Filter Instructions for Use) or remain implanted as a permanent filter.” |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Cordis has updated the Warning statement in accordance with regulatory requirements as follows:
"The OPTEASE Retrievable Filter has not been studied for long term implantation and must be retrieved within 12 days after placement."
Previous Warning statement:
“The OPTEASE Retrievable filter can be retrieved up to and including 12 days after placement. The OPTEASE Retrievable filter is considered a permanent implant if it is not retrieved within the specified time period.”
The statement below was removed from the device description for the OPTEASE Retrieval Catheter in accordance with the updates made to the Warning statement in the IFU for the Cordis OPTEASE Retrievable Vena Cava Filter and OPTEASE Retrieval Catheter:
“The OPTEASE Retrievable Filter can be retrieved within a specified period after implantation (refer to the OPTEASE Retrievable Filter Instructions for Use) or remain implanted as a permanent filter.”
This action has been closed out on 26/3/2024. |
| Contact Information |
ANZ-Product-Complaints@cordis.com - Cordis |