FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
- Recall number
- Z-2752-2026
- Recalling firm
- Boston Scientific Corporation
- Product
- FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
- Status
- Open, Classified
- Initiated
- 2026-06-11
- Posted
- 2026-07-17
- Terminated
- not on file
- Reason
- Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 11 units
- Distribution
- International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
- Lot, serial or model codes
- GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.
- 510(k) numbers
- not on file
- PMA numbers
- ["P230030","P230030S012"]
- Product code
- QZI
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28