FDA-Device2026-10-21Class IIPROCESSING DEFECT
Boston Scientific NaviFlex LW Pusher pancreatic stent recalled for incorrect manufacturing defect
What this means
Boston Scientific discovered that 403 units of the NaviFlex LW Pusher Advx Panc. Stent were incorrectly manufactured with an extra guidewire exit port that should not be present on this device model. This manufacturing error could affect how the device performs during use.
- If you have one of the affected lot numbers (38904309, 39017263, or 39365322), contact your healthcare provider or Boston Scientific immediately.
- Do not use the device if you have confirmed you have an affected lot number.
- Healthcare facilities should quarantine affected inventory and follow guidance from Boston Scientific.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
403
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0143-2027More Boston Scientific recalls
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