Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 13088 |
| Brand Name: | EV3 Onyx Liquid Embolic Systems |
| Model: | All models |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Lifehealthcare Ltd New Zealand Unit E 61 Hugo Johnston Drive Penrose Auckland 1642 |
| Contact Information: | |
| Manufacturer: | Micro Therapeutics Inc dba ev3 Neurovascular |
| Issue: | FDA notified physicians and patients about the risk of catheter entrapment associated with the use of Onyx. Catheter entrapment happens when the catheter becomes stuck in the implanted Onyx material. The most serious complications include hemorrhage and death. Other complications include migration of the Onyx plug or catheter fragment to other parts of the body. Patients with catheter entrapment may need to take antithrombotic drugs to prevent blood clots around the catheter, and may need to undergo one or more imaging procedures to locate a piece of the catheter and Onyx plug, increasing their exposure to radiation. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 1/8/2012 |
