CLASS II ONGOING Device recall · Reported 21 Oct 2026 · FDA Enforcement Report

NaviFlex LW Pusher recalled by Boston Scientific

Boston Scientific is recalling NaviFlex LW Pusher, distributed nationwide in the US. The recall was initiated on 10 Sep 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;

Quantity recalled403

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-0143-2027
FDA event ID: 99829
Recalling firm: Boston Scientific, Marlborough, MA
Classification: Class II
Status: Ongoing
Recall initiated: 10 Sep 2026
FDA classified: 9 Oct 2026
Reported: 21 Oct 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

10 Sep 2026	Recall initiated by company
9 Oct 2026	Classified by FDA	+29 days
21 Oct 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

Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.

Product as listed by the FDA

NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;

Where it was distributed

US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC, NH, NM, NY, RI, TX, WA, WI, WV and the countries in TBD.

Nationwide Alabama California Florida Georgia Illinois Indiana Kentucky Maryland North Carolina New Hampshire New Mexico New York Rhode Island Texas Washington Wisconsin West Virginia

Questions about this recall

Why was it recalled?

Device was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port), which is not a design feature associated with this device configuration.

Which lots are affected?

Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;

Where was it sold?

US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD, NC, NH, NM, NY, RI, TX, WA, WI, WV and the countries in TBD.

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 27 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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