Polarx Fit Cryoablation Balloon Catheter
SMARTFREEZE Cryo-Console Recall Boston Scientific Corporation is recalling the SMARTFREEZE Cryo-Console distributed to hospitals, pharmacies, and laboratories in New Zealand. The product is being returned to the supplier. This is classified as a Class I recall, which indicates a serious issue with the product.
- Recalling firm
- Boston Scientific NZ Ltd
- Product
- POLARx Fit Cryoablation Balloon Catheter. [Device]. Affected: Material number - M004CRBS2010; Material number - M004CRBS2100; Material number - M004CRBS3050; Material number - M004CRBS4000. Also covers: POLARx Cryoablation Balloon Catheter; POLARSHEATH Steerable Sheath; SMARTFREEZE Cryo-Console
- Reason
- 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...
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-04-13
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/5f5ce8c0-d902-4ef8-ba0c-512b84e32245