Z-0143-2027

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

Name: Z-0143-2027 NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030
Creator: Boston Scientific Corporation
Published: 2026-09-10
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-09-10 / Open, Classified

FDA source

Recall record

Recall number: Z-0143-2027
Status: Open, Classified
Initiated: 2026-09-10
Posted: 2026-10-09
Recalling firm: Boston Scientific Corporation
Product: NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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.
FDA root cause: Under Investigation by firm
Action: On September 10, 2026, Urgent Medical Device Removal letters were sent to customers. Actions to be taken: 1. Immediately stop further use or distribution and segregate affected product (see Attachment 1 for identification of the affected devices). 2. Continue to follow the standard of care when monitoring patients treated with the product. 3. Complete and return the enclosed Reply Verification Tracking Form per the included instructions. 4. Return product to Boston Scientific in accordance with the enclosed instructions. 97657220-FA Advanix Pancreatic LW Pusher. 5. Forward this notice to relevant personnel and any facilities to which the product was transferred.
Quantity in commerce: 403
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.
Product codes and lots: Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;

Product code FGE

K223592Class IIAdvanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and PushersBoston Scientific Corporation / cleared 2022-12-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)