Official recall notice
FDA DeviceClass IINotable
FDA Recall: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car
- Recall date
- 2026-07-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Product description
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Affected products
GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.