| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01311-1 |
| Product Name/Description |
Copernic2L and Eclipse2L Occlusion Balloon Catheters
All Lot Numbers
ARTG Numbers:
263592 (Getz Healthcare Pty Ltd - COPERNIC 2L occlusion balloon catheter - Catheter, intravascular, occluding) and;
263593 (Getz Healthcare Pty Ltd - ECLIPSE 2L occlusion balloon catheter - Catheter, intravascular, occluding) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
31/10/2017 |
| Responsible Entity |
|
| Reason/Issue |
Getz Healthcare is advising that damages on the catheters' tubes have been observed during post-marketing surveillance program. This may lead to unusual balloon behaviour during the contrast liquid injection through the guiding catheter, such as unexpected inflation and/or difficult deflation.
The manufacturer, Balt Extrusion has received 3 reports of cases involving this issue, but there have been no reports of patient injury due to these types of failures on the devices. However, these kinds of incidents may lead to patient injury with vascular trauma if the devices are not used in accordance with the recommendations. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Getz Healthcare is advising users to not insert the double lumen catheters ECLIPSE2L and COPERNIC2L through the Y connector's side-arm; they shall be inserted through the axial-arm to prevent any deterioration of the tube. The Instructions for Use will be updated as a permanent measure.
This action was closed out on the 25/09/2018. |
| Contact Information |
1300 668 440 - Getz Healthcare Customer Service |