FDA Device recall Z-0143-2027
NaviFlex LW Pusher
- FDA Device
- Class II
- ongoing
- Published 2026-10-21
On 2026-10-21 the FDA classified a Class II recall of NaviFlex LW Pusher by Boston Scientific, citing 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 FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0143-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-10 |
| Published | 2026-10-21 |
| Last updated | 2026-10-27 05:30 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
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.
Identifiers
| code_info | Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-27 05:30 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-09 · Boston Scientific - LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
FDA Device · Class II · 2026-09-09 · Boston Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0143-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.