Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29252 |
| Brand Name: | Dragonfly OpStar™ Imaging Catheter |
| Model: | 1014652 |
| Affected: | 8157506 |
| Software version: | |
| Recalling Organisation: | Abbott Laboratories (NZ) Ltd Unit D 4 Pacific Rise Mt Wellington Auckland 2025 |
| Contact Information: | 0800 656 233 |
| Manufacturer: | Abbott Medical (USA) |
| Issue: | The manufacturer has identified that the proximal marker on device may separate from the device. A dislodged marker may require additional intervention, including unplanned additional coronary intervention, or surgery. One which resulted in an embolism which required an additional intervention to resolve with no immediate adverse consequences. Potential risks include embolism, cardiovascular injury and myocardial ischemia. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 12/4/2022 |
