Boston Scientific Ltd.
⚠️ High Risk
FEI: 3002618605 • Clonmel • IRELAND
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
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 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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/13/2026 | 87NQOPROSTHESIS, SPINOUS PROCESS SPACER/PLATE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/12/2018 | 78FAEPROSTHESIS, PENILE | Division of Southeast Imports (DSEI) | |
| 8/24/2018 | 74LWPPULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 3/12/2014 | 74NIKDEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATION | Division of Southeast Imports (DSEI) | |
| 12/17/2012 | 74KREANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 12/17/2012 | 74DXQCUFF, BLOOD-PRESSURE | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/20/2012 | 74DTDADAPTOR, LEAD, PACEMAKER | New Orleans District Office (NOL-DO) | |
| 6/20/2012 | 74DTDADAPTOR, LEAD, PACEMAKER | New Orleans District Office (NOL-DO) | |
| 2/23/2011 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/28/2011 | 74DTDADAPTOR, LEAD, PACEMAKER | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Boston Scientific Ltd.'s FDA import refusal history?
Boston Scientific Ltd. (FEI: 3002618605) has 10 FDA import refusal record(s) in our database, spanning from 1/28/2011 to 1/13/2026.
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 Ltd.'s FEI number is 3002618605.
What types of violations has Boston Scientific Ltd. received?
Boston Scientific Ltd. 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 Ltd. come from?
All FDA import refusal data for Boston Scientific Ltd. 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.