Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 28492 |
| Brand Name: | Biliary Balloon Catheters ex-Cork |
| Model: | |
| Affected: | Multiple Lot numbers |
| 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 reported for pinholes in the balloon.The user may notice that the balloon either rapidly loses pressure or fails to gain or maintain pressure. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/10/2021 |
