Recall Z-0143-2027
- Recall number
- Z-0143-2027
- Event number
- 99829
- Firm
- Boston Scientific Corporation
- Firm FEI
- 3005099803
- Product code
- FGE
- Status
- Open, Classified
- Initiated
- 2026-09-10
- Posted
- 2026-10-09
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K223592, K993892, K051124, K033393, K051379, K993904, K183396, K223626, K031197, K050103, K011881, K101314, K002143, K093947, K905707, K020809, K113582, K221071, K992318, K011184, K993091, K180418, K031186, K241801, K924451, K112543, K093003, K955728, K030107, K901432
Product#
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Reason for Recall#
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.