Recall Z-2752-2026
Boston Scientific Corporation · initiated June 11, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Codes / lots: GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.
Reason for recall
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA-determined cause: Under Investigation by firm
Action taken
Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Correction notice to its consignees out side the US on 6/11/2026 via hand delivered letter. The notice explained the issue and requested the following actions be taken: Instructions: 1- Post a copy of the appropriate IFU provided near each FARASTAR PFA generator, replacing any previous versions currently in use. 2- Review the IFU and ensure all relevant personnel are aware of its contents. 3- Please complete the attached Acknowledgement Form even if you do not have any affected product and return it to your Boston Scientific office. 4- Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which this product may have been transferred. The national Competent Authority was informed of this communication. Any adverse events or quality concerns associated with use of these devices should be reported to Boston Scientific and Competent Authorities if appropriate.
Details
- Recall number
- Z-2752-2026
- Initiated
- June 11, 2026
- Posted by FDA
- July 17, 2026
- Product code
- QZI – Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Quantity
- 11 units
- Distribution
- International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
- Recalling firm
- Boston Scientific Corporation, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2750-2026 Class II | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401…Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA… | 06/11/2026Open, Classified |
| Z-2751-2026 Class II | FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous…Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA… | 06/11/2026Open, Classified |