- Recalling firm
- Boston Scientific Corporation
- 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.
- Affected products (lot / model / serial)
- GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
- Units affected
- 6 units
- Distribution pattern
- International distribution in the countries of Italy, Austria, France, Germany, Belgium.
- Firm location
- Saint Paul, MN, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2753-2026
- Recall initiated
- June 11, 2026
- FDA classification date
- July 17, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99251
- Last updated on HTM Vibe
- August 4, 2026