Z-2750-2026Class II

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

Name: Z-2750-2026 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 / root cause: labeling and UDI

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 "Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2750-2026
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: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Root cause tag: labeling and UDI
FDA 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 in commerce: 18 units
Distribution: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2750-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2750-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17
Z-2751-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-17
Z-2752-2026	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)