CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report

Farastar PFA Generator, Product ID M004PFCE61M460 recalled

Boston Scientific is recalling Farastar PFA Generator, Product ID M004PFCE61M460. The recall was initiated on 11 Jun 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.

Quantity recalled11 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2752-2026
FDA event ID: 99230
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 11 Jun 2026
FDA classified: 17 Jul 2026
Reported: 29 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

11 Jun 2026	Recall initiated by company
17 Jul 2026	Classified by FDA	+36 days
29 Jul 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Product as listed by the FDA

FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter

Where it was distributed

International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.

Questions about this recall

Why was it recalled?

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Which lots are affected?

GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.

Where was it sold?

International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 99230

This product is part of a recall event; the main page for the event is Farastar Ablation Generator EU recalled by Boston Scientific.

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026	CLASS II	Farastar Ablation Generator EU recalled by Boston Scientific	Boston Scientific	Other	MN
29 Jul 2026	CLASS II	Farastar Pulsed Field Ablation Generator, Product ID M004PFCE61M401 recalled	Boston Scientific	Other	MN

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