NaviFlex LW Pusher recallZ-0143-2027 · Boston Scientific Corporation · initiated Sep 10, 2026
Open, Classified All recalls posted in October 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0143-2027
- Recall class
- Not yet classified by the FDA
- Status
- Open, Classified
- Initiated by the company
- Sep 10, 2026
- Posted by the FDA
- Oct 9, 2026
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 403
- Product code
- FGE
- FDA submissions
- K223592
- 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 description
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Code information (models, lots, serial numbers)
Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NaviFlex™ Pusher M00535030Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall46 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page