Z-2753-2026Class II

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac...

Name: Z-2753-2026 FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac...
Creator: Boston Scientific Corporation
Published: 2026-06-11
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-06-11 / Open, Classified

FDA source

Boston Scientific Corporation began a recall of FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter on 2026-06-11. FDA classified it as Class II and gives the reason as "Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2753-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-11
Posted: 2026-07-17
Recalling firm: Boston Scientific Corporation
Product: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Product code: QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Reason for recall: Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
FDA 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 in commerce: 6 units
Distribution: International distribution in the countries of Italy, Austria, France, Germany, Belgium.
Product codes and lots: GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2753-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2753-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17

Product code QZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)