| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00715-1 |
| Product Name/Description |
Cordis EMPIRA NC RX PTCA Dilatation Catheter (“75RxxyyyN”) and Cordis EMPIRA RX PTCA Dilatation Catheter (“85RxxyyyS”)
(indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion)
All Catalogue Numbers and all unexpired Lots |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
4/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Through the investigation of the complaints, Cordis and Creganna-Tactx have observed that the balloon of the affected product, which is covered with a hydrophilic coating, may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. Use of a weakened catheter may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery. There is no concern for patients who have already been treated successfully with the affected product. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical is advising end users that if unusual force is required during the removal of the shipping stylet and/or balloon cover, the unit is not be used. This warning is also being added to the product labelling.
This action was closed out on the 09/10/2018. |
| Contact Information |
1800 252 194 - JJM Customer Service |