FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- Recall number
- Z-2753-2026
- Recalling firm
- Boston Scientific Corporation
- Product
- FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
- Status
- Open, Classified
- Initiated
- 2026-06-11
- Posted
- 2026-07-17
- Terminated
- not on file
- Reason
- Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
- Root cause
- Under Investigation by firm
- Action
- Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Recall 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: 2- Allow Boston Scientific representative(s) to replace affected FARASTAR PFA generators. 3- Please complete the attached Verification Form even if you do not have any product to return and send it to your local Boston Scientific office 4- If you have products to return, please package them in an appropriate shipping box. After receipt of the Verification Form, Boston Scientific will contact you to arrange return. 6- Please pass this notice to any health professional from your organization that needs to be aware, and to any organization where the potentially affected devices have been transferred (if appropriate). Please provide Boston Scientific with details of any affected devices that have been transferred to other organizations (if appropriate). The National Competent Authority has been informed of this communication.
- Quantity
- 6 units
- Distribution
- International distribution in the countries of Italy, Austria, France, Germany, Belgium.
- Lot, serial or model codes
- GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
- 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