Home / Import refusals / 799-2350966-8/10002/1

FDA Import Refusal 799-2350966-8/10002/1 — Boston Scientific Ltd.

Boston Scientific Ltd. — FEI 3002618605

The FDA refused shipment 799-2350966-8/10002/1 from Boston Scientific Ltd. (Ireland) on January 13, 2026. The refused product falls under Devices — PROSTHESIS, SPINOUS PROCESS SPACER/PLATE. Cited charge: 341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
January 13, 2026
Country
Ireland
Product Category
Devices
Product Code
87NQO PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Charges
341

Recent inspections

  • 1034546 (NAI Thu Jul 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 818503 (NAI Thu Jan 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 717007 (NAI Thu Feb 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-3410642-5/11/1 (Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-5125368-7/11/1 (Wed Sep 12 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-4653739-2/11/1 (Fri Aug 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-1143705-6/1/2 (Wed Mar 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0414838-7/1/2 (Mon Dec 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources