- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Affected products (lot / model / serial)
- GTIN 00191506042547, Serial Numbers: 106247020.
- Units affected
- 1 units
- Distribution pattern
- International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
- 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-2751-2026
- Recall initiated
- June 11, 2026
- FDA classification date
- July 17, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99230
- Last updated on HTM Vibe
- August 4, 2026