Boston Scientific Corporation recalls NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
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.
Read the official notice →- Date
- 2026-10-21
- Country
- United States
- Brand
- Boston Scientific
- Product
- NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, IN, KY, MD,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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