Recall Weekly
Moderate riskFDA DeviceClass II

Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions

Boston Scientific distributed 18 FARASTAR Ablation Generator units in Europe with incomplete Instructions For Use (IFU). The labeling did not include information about the FARAPOINT PFA catheter, which is used with the device. This discrepancy could affect proper device setup and use.

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

What to do

  1. If you operate or maintain one of the affected units, contact Boston Scientific immediately for corrected instructions
  2. Do not discard the device; follow Boston Scientific's guidance on obtaining complete labeling
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; 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
18 units
Illnesses reported
None reported
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Classification
Class II
Recall number
Z-2750-2026

In the FDA's words

Description
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. 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. Distribution: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland. Affected quantity: 18 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.

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