POLARx and POLARx FIT Cryoablation Catheters, POLARSHEATH Steerable Sheaths, and SMARTFREEZE Consoles

Brief description of the problem (reason for recall)

This recall has been initiated due to the availability of new alternative ablation technologies and recent reports of atrio-esophageal (AE) fistula events.

Advice for health professionals and distributors:

Immediately stop further use or distribution and segregate all POLARx and POLARx FIT Catheters, POLARSHEATH sheaths, and SMARTFREEZE consoles listed above.

• Continue to follow the standard of care post ablation when monitoring patients treated with POLARx and POLARx FIT Cryoablation products.
• Return POLARx and POLARx FIT catheters and POLARSHEATH sheaths to Boston Scientific in accordance with the below instructions.
• A Boston Scientific representative will contact your facility to schedule a time to decommission your SMARTFREEZE Console.
• Share this communication with any healthcare professionals in your hospital that use the Boston Scientific POLARx Cryoablation System and with any other organization to which these systems may have been transferred.
• Call your Boston Scientific representative with any questions about credits and/or recall/destruction of other components.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.