Urgent Field Safety Notice For Polarx Fit And Polarx, Polarsheath, Smartfreeze Console By Boston Scientific Corporation Marlborough
Boston Scientific is recalling POLARx FIT and POLARx cryoablation consoles with POLARSHEATH and SMARTFREEZE components sold in Germany and the EU due to a safety issue identified in a risk assessment. This is a Class I recall, indicating a serious problem. The notice requires corrective field actions to address the identified risk.
- Recalling firm
- Urgent Field Safety Notice for POLARx FIT and POLARx, POLARSHEATH, SMARTFREEZE Console by Boston Scientific Corporation
- Product
- s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for POLARx FIT and POLARx, POLARSHEATH, SMARTFREEZE Console by Boston Scientific Corporation Marlborough 2026
- Reason
- assessment Field corrective actions Urgent Field Safety Notice for POLARx FIT and POLARx, POLARSHEATH, SMARTFREEZE Console by Boston Scientific Corporation Marlborough 2026
- Classification
- Class I
- Category
- medical device recall
- Country
- Germany
- Agency
- BFARM
- Recall date
- 2026-04-20
- Status
- Ongoing
- Distribution
- Germany / EU
Official recall notice from BFARM
Recall details on Nibble Recalls: https://trynibble.app/recalls/5312f487-56ca-42ec-9dd8-8749d4e878cd