CLASS II ONGOING Device recall · Reported 16 Jul 2025 · FDA Enforcement Report

VersaCross RF Wire (VXW) recalled by Boston Scientific

Boston Scientific is recalling VersaCross RF Wire (VXW), distributed nationwide in the US. The recall was initiated on 10 Jun 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00685447006121 Lot 35935598

Quantity recalled14,724

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-2104-2025
FDA event ID: 97036
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class II
Status: Ongoing
Recall initiated: 10 Jun 2025
FDA classified: 10 Jul 2025
Reported: 16 Jul 2025
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Other Medical Devices

Timeline

10 Jun 2025	Recall initiated by company
10 Jul 2025	Classified by FDA	+30 days
16 Jul 2025	Published in enforcement report	+6 days

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

Reason for recall

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 00685447006121 Lot 35935598

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

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

3 other products · FDA event 97036

This product is part of a recall event; the main page for the event is Torflex Transseptal Guiding Sheath Kit recalled by Boston Scientific.

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025	CLASS II	Torflex Transseptal Guiding Sheath Kit recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide
16 Jul 2025	CLASS II	VersaCross Access Solution (Vxsk), Product Description recalled	Boston Scientific	Sterility	Nationwide
16 Jul 2025	CLASS II	VersaCross Transseptal Sheath Kit recalled by Boston Scientific	Boston Scientific	Sterility	Nationwide

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