| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00402-1 |
| Product Name/Description |
NC Trek Rx Coronary Dilatation System
Multiple Part and Lot Numbers
ARTG Number: 189474 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/03/2017 |
| Responsible Entity |
|
| Reason/Issue |
Specific lots of the NC Trek RX Coronary Dilatation Catheter have been identified to potentially exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The worldwide frequency of tight sheath removal, inflation and deflation reported events is 0.12%. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction. In one reported case, failure to deflate the balloon necessitated surgery, leading to multiple post-operative complications and death.
Please note that this action does not affect patients having successfully undergone cardiac procedures using these devices. |
| Recall Action |
Recall |
| Recall Action Instructions |
Abbott Vascular is advising users to refer to the list of affected part numbers and lot numbers in their recall letter. If affected stock is identified, users are requested to immediately cease using these devices, complete and return the Effectiveness Check Form prior to the return of all unused products to Abbott Vascular.
This action has been closed-out on 22/03/2018. |
| Contact Information |
1800 550 939 - Abbott Vascular Customer Service |