Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36721 |
| Brand Name: | POLARx Fit Cryoablation Balloon Catheter |
| Model: | |
| Affected: | Material number - M004CRBS2010 |
| 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: | POLARx Cryoablation Balloon Catheter |
| Model: | |
| Affected: | Material number - M004CRBS2100 |
| 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: | POLARSHEATH Steerable Sheath |
| Model: | |
| Affected: | Material number - M004CRBS3050 |
| 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: | SMARTFREEZE Cryo-Console |
| Model: | |
| Affected: | Material number - M004CRBS4000 |
| 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 made the decision to discontinue this cardiac cryoablation product line, and thereafter ceased manufacturing catheters and consoles. Given the availability of new alternative ablation technologies and recent reports of atrio-esophageal Adverse Events (AE) fistula events - despite occurrence rates remaining within expected and documented range - the manufacturer is accelerating discontinuation of the POLARx Cryoablation System. Patients previously treated with the System should continue to be managed according to standard of care, with any additional management at the discretion of the treating physician. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 13/4/2026 |
