FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Summary
The FDA issued a Class II for FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneou by Boston Scientific Corporation. Reason: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information..
Details
Source
Device Recall
External ID
Z-2751-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Lot/Code Info: GTIN 00191506042547, Serial Numbers: 106247020.
Quantity Affected: 1 units
Reason for Recall
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Distribution
International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-11
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Boston Scientific Corporation has 414 FDA actions in our database, including 345 recalls and 69 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 414 FDA actions in our database, including 345 recalls and 69 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2751-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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