Home / Import refusals / AEK-4653739-2/11/1

FDA Import Refusal AEK-4653739-2/11/1 — Boston Scientific Ltd.

Boston Scientific Ltd. — FEI 3002618605

The FDA refused shipment AEK-4653739-2/11/1 from Boston Scientific Ltd. (Ireland) on August 24, 2018. The refused product falls under Devices — PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE. Cited charge: 3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 24, 2018
Country
Ireland
Product Category
Devices
Product Code
74LWP PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Charges
3280

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

  • 799-2350966-8/10002/1 (Tue Jan 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 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-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