- 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 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307.
- Units affected
- 18 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-2750-2026
- 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