| TGA Action ID |
RC-2026-RN-00262-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Boston Scientific Cardiac Cryoablation System
Boston Scientific POLARx and POLARx FIT Cryoablation Balloon Catheters, POLARSHEATH Steerable Sheaths, and SMARTFREEZE Cryoablation System Consoles
ARTG 367270 - Cancelled |
| ARTG Number |
330226, 367272, 409910 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
In 2024, Boston Scientific notified physicians of potential risk of atrio-oesophageal (AE) fistula associated with POLARx and POLARx FIT catheters. Although rare, AE fistula is a known and inherent risk for patients undergoing catheter ablation for atrial fibrillation due to the anatomical proximity of the oesophagus to the posterior left atrium (RC-2024-RN-00893-1).
In recent months, three AE fistula occurrences have been reported, including one associated with a patient death. The observed complaint rate (0.0103%) remains below the range of published societal rates for oesophageal injury following AF ablation procedures (up to 0.2%) and the predefined risk threshold for the system’s performance. None of these complaints occurred in Australia. A review of these events did not identify any product performance-related problems with components of the System. Overall, the observed AE fistula rate for the catheters remains within established risk thresholds and is consistent with published clinical guidelines.
Although AE fistula occurrence remains within anticipated rates, alternative technologies are available with evidence demonstrating reduced risk of thermally mediated injury. Considering these alternatives, prior decisions to discontinue the product line, and recent AE fistula events, Boston Scientific is accelerating discontinuation through removal of POLARx and POLARx FIT catheters and POLARSHEATH sheaths, and decommissioning SMARTFREEZE consoles. |
| Instructions for Customers/Users |
Customers are to:
· Immediately stop further use or distribution and segregate all POLARx and POLARx FIT catheters, POLARSHEATH Sheaths, and SMARTFREEZE consoles.
· Continue to follow the standard of care post ablation when monitoring patients treated with POLARx and POLARx FIT Cryoablation products.
· Complete and return the enclosed Customer Response Form per the included instructions.
· Return POLARx and POLARx FIT catheters and POLARSHEATH sheaths to Boston Scientific in accordance with the enclosed instructions.
· A Boston Scientific representative will contact customers to schedule a time to decommission the SMARTFREEZE consoles. Customers will be consulted to identify the most suitable method for the physical disposal of the console. |
| Action Commencement Date |
14/04/2026 |
| Responsible Entity |
|
| Contact Information |
ANZ_Incident_Report@bsci.com - Boston Scientific |