Boston Scientific Corporation — NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Official product recall notices and clearly labeled enforcement reference records.
Reference record — not a live warning · enforcement-reference · official-source
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.
- Posted by source
- Source last updated
- Current version retrieved
- Provider
- FDA — device enforcement reference
- Location
- Marlborough, MA, US
- 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.
- notice
- Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
- product
- NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
- 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.
- event number
- 99829
- manufacturer
- Boston Scientific Corporation
- recall number
- Z-0143-2027
- source status
- Open, Classified
- freshness minutes
- 180
Source use policy · openFDA reference data; not a real-time public alert service
Update history (1 recent revisions)
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