Boston Scientific Corporation
⚠️ High Risk
FEI: 3005099803 • Marlborough, MA • UNITED STATES
FEI Number
3005099803
Location
Marlborough, MA
Country
UNITED STATESAddress
100 Boston Scientific Way, , Marlborough, MA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 90IXKSYSTEM, IMAGING, X-RAY, ELECTROSTATIC | Division of West Coast Imports (DWCI) | |
| 5/28/2025 | 74DQXWIRE, GUIDE, CATHETER | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 74DQXWIRE, GUIDE, CATHETER | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 74MAVSYRINGE, BALLOON INFLATION | 2480RXPERSONAL | Division of Southeast Imports (DSEI) |
| 5/18/2021 | 78PCUPANCREATIC STENT, COVERED, METALLIC, REMOVABLE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Boston Scientific Corporation's FDA import refusal history?
Boston Scientific Corporation (FEI: 3005099803) has 6 FDA import refusal record(s) in our database, spanning from 5/18/2021 to 9/24/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Boston Scientific Corporation's FEI number is 3005099803.
What types of violations has Boston Scientific Corporation received?
Boston Scientific Corporation has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Boston Scientific Corporation come from?
All FDA import refusal data for Boston Scientific Corporation is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.