Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 26573 |
| Brand Name: | Biliary Balloon Catheters ex-Cork |
| Model: | |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Cork Ltd |
| Issue: | The manufacturer is initiating a removal of specific lots/batches of Hurricane™ RX Biliary Balloon Dilatation Catheters in response to an increase in complaints of the RX tunnel component (black sheath) detaching from the catheter shaft. Investigation has shown this is due to a lower bond strength of the tunnel component which may lead to detachment. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 17/9/2020 |
