Database updated: 3 November 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37769 |
| Brand Name: | OptiCross |
| Model: | Material Number: H749518100, H749518120 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Brand Name: | Opticross HD 60 MHz Coronary Imaging Catheter |
| Model: | Material number: H74939352020, H74939352060 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Brand Name: | Opticross 6 HD 60 MHz Coronary Imaging Catheter |
| Model: | Material number: H74939354060, H74939354100 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Brand Name: | OptiCross(TM) 18 30 MHz Peripheral Imaging Catheter |
| Model: | Material number: H7493932700180 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Boston Scientific NZ Ltd 3 Diamond Street Eden Terrace Auckland 1021 |
| Contact Information: | 0800 742 678 |
| Manufacturer: | Boston Scientific Corporation |
| Brand Name: | OptiCross 35 15 MHz Peripheral Imaging Catheter |
| Model: | Material number: H7493932800350 |
| Affected: | |
| 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 notifying customers of updated flushing instructions for the OptiCross™ family of intravascular ultrasound (IVUS) imaging catheters, reinforcing device preparation and air-management practices, and advising of forthcoming updates to the Instructions for Use (IFU). The updated IFU will remove instructions allowing flushing while the catheter is positioned within the patient when entrapped air is suspected and will further clarify device preparation and air-management procedures. The affected catheters remain available for use. Until the revised IFU is issued, users should continue to follow the current IFU except where superseded by the instructions contained in this communication. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/10/2026 |
