Urgent Field Safety Notice For Farastar Pulsed Field Ablation Generator By Boston Scientific Corporation Marlborough

Recall Summary Boston Scientific is issuing an urgent field safety notice for its FARASTAR Pulsed Field Ablation Generator devices distributed in Germany and the EU. This is a Class I recall, the most serious classification. The specific reason for the recall is not clearly stated in the provided document.

Recalling firm
Urgent Field Safety Notice for FARASTAR Pulsed Field Ablation Generator by Boston Scientific Corporation Marlborough , D
Product
s Tasks of the BfArM Risk assessment Field corrective actions Urgent Field Safety Notice for FARASTAR Pulsed Field Ablation Generator by Boston Scientific Corporation Marlborough 2026
Reason
assessment Field corrective actions Urgent Field Safety Notice for FARASTAR Pulsed Field Ablation Generator by Boston Scientific Corporation Marlborough 2026
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-06-17
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/040cefd5-506f-4ad7-a2df-89366e91943f