Recall Weekly
Moderate riskFDA DeviceClass II

Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling

Boston Scientific distributed 11 FARASTAR PFA Generator devices with Instructions For Use 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

  1. Check if you have one of the affected serial numbers (106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816).
  2. Contact Boston Scientific for corrected labeling or instructions on next steps.
  3. Do not use the device until you receive complete Instructions For Use.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
FARASTAR PFA Generator, Product ID M004PFCE61M460; 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
11 units
Illnesses reported
None reported
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Classification
Class II
Recall number
Z-2752-2026

In the FDA's words

Description
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816. Distribution: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland. Affected quantity: 11 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.

More from Boston Scientific

See all

Related topics

OtherMedical devicesSold nationwideMore from FDA Device