Boston Scientific Corporation recalls NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number
See all recalls from Boston Scientific Corporation →Recalled Product
NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Material Number (UPN): M00535030; UDI-DI: 08714729856191; Lot Number: 38904309, 39017263, 39365322;
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for NaviFlex LW Pusher; →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime