Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 35 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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 this device configuration. |
| Product | NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030; |
| Quantity | 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. |
| Initiated | 2026-09-10 |
| Classified | 2026-10-09 |
| Recall number | Z-0143-2027 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-29. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-0143-2027).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-29. https://regwarden.com/recall/99829/
Alerts for Boston Scientific Corporation
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.