Home / Import refusals / AEK-6657941-4/1/1

FDA Import Refusal AEK-6657941-4/1/1 — Boston Scientific Corporation

Boston Scientific Corporation — FEI 2124215

The FDA refused shipment AEK-6657941-4/1/1 from Boston Scientific Corporation (United States) on April 13, 2005. The refused product falls under Devices — PULSE-GENERATOR, PACEMAKER, IMPLANTABLE. Cited charges: 118,237 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 13, 2005
Country
United States
Product Category
Devices
Product Code
74DXY PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
Charges
118,237

Recent inspections

  • 1257844 (OAI Mon Apr 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1215054 (NAI Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1157921 (NAI Fri Oct 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066347 (NAI Tue Jul 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1032428 (NAI Wed Nov 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-1898115-2/10001/2 (Wed Sep 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9104782-3/31/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9104782-3/41/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9104782-3/21/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-9104782-3/11/1 (Wed May 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources