Moderate riskFDA DeviceJul 29, 2026Class II

Boston Scientific FARASTAR PFA Generator recalled for incomplete instructions

Boston Scientific distributed one FARASTAR Pulsed Field Ablation Generator with instructions that were missing information about the FARAPOINT PFA catheter. The incomplete labeling could affect proper device use and patient safety.

From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls

What to do

If you received this device, contact Boston Scientific for updated instructions
Do not use the device until you have complete labeling information

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Sold in: Nationwide
Made for: All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected: 1 units
Illnesses reported: None reported
Manufactured in: 4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Classification: Class II
Recall number: Z-2751-2026

In the FDA's words

Description: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. GTIN 00191506042547, Serial Numbers: 106247020. Distribution: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland. Affected quantity: 1 units
Hazard: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

3 products in this recall

Boston Scientific FARASTAR generators recalled for labeling error

Boston Scientific is recalling three FARASTAR pulsed field ablation generator products because the instructions for use shipped with them did not include information about the FARAPOINT PFA catheter. A total of 30 units were affected, distributed in Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, and Ireland. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Z-2750-2026 · 18 units
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter (this page)
Z-2751-2026 · 1 units
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Z-2752-2026 · 11 units