NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Summary
The FDA issued a Class II for NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030; by Boston Scientific Corporation. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0143-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Lot/Code Info: Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;
Quantity Affected: 403
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.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-10
Company
Marlborough, MA
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 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Boston Scientific Corporation has 421 FDA actions in our database, including 356 recalls and 65 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 421 FDA actions in our database, including 356 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0143-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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