Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18056 |
| Brand Name: | Cordis Empira NC Rx PTCA Catheter |
| Model: | All catalogue numbers 75RxxyyyN |
| Affected: | All unexpired lots |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (New Zealand) Limited 507 Mt Wellington Highway Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Creganna-Tactx Medical (USA) |
| Brand Name: | Cordis Empira Rx PTCA Catheter |
| Model: | All catalogue numbers 85Rxx777S |
| Affected: | All unexpired lots |
| Software version: | |
| Recalling Organisation: | Johnson & Johnson (New Zealand) Limited 507 Mt Wellington Highway Mt Wellington AUCKLAND 1060 |
| Contact Information: | 0800 922 638 |
| Manufacturer: | Creganna-Tactx Medical (USA) |
| 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 type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 9/2/2015 |
