Z-2753-2026 Class II Ongoing
FDA device recall Z-2753-2026 was initiated by Boston Scientific Corporation on June 11, 2026 and is designated Class II. Reason for recall: Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Reason for Recall
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Distribution Pattern
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
Code Information
GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.