Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37560 |
| Brand Name: | Direxion and Direxion HI-FLO Intravascular microflow catheter |
| Model: | Direxion and Direxion HI-FLO |
| Affected: | Multiple batches |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Issue: | The manufacturer is initiating the removal of specific lots of DirexionTM and Direxion HIFLOTM Microcatheters due to a manufacturing issue that may cause difficulty withdrawing the device from the carrier hoop and difficulty advancing or withdrawing the device through a guide catheter. The problem is detectable during device preparation and/or use in the patient and is experienced as increased resistance between the microcatheter and other components. This increased resistance, including attempts to advance or withdraw the device when resistance is encountered, may result in damage to the microcatheter. Potential adverse health consequences include prolonged procedure, vessel trauma, vasospasm, additional intervention to retrieve a separated device fragment, unretrieved device fragment, thrombosis, or embolism. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/9/2026 |
