Home / Import refusals / AEK-1143705-6/1/2

FDA Import Refusal AEK-1143705-6/1/2 — Boston Scientific Ltd.

Boston Scientific Ltd. — FEI 3002618605

The FDA refused shipment AEK-1143705-6/1/2 from Boston Scientific Ltd. (Ireland) on March 12, 2014. The refused product falls under Devices — DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 12, 2014
Country
Ireland
Product Category
Devices
Product Code
74NIK DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION
Charges
118,508

Recent inspections

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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-4653739-2/11/1 (Fri Aug 24 2018 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