MicroVention Costa Rica S.R.L.
⚠️ High Risk
FEI: 3010079067 • Alajuela, Alajuela • COSTA RICA
FEI
FEI Number
3010079067
📍
Location
Alajuela, Alajuela
🇨🇷
Country
COSTA RICA🏢
Address
Coyol Free Zone, B 33, Zona Franca Coyol, Edificio B33, El Coyol De Alajuela, Alajuela, Alajuela, Costa Rica
High Risk
FDA Import Risk Assessment
66.7
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
76
Total Refusals
2
Unique Violations
11/17/2025
Latest Refusal
10/4/2013
Earliest Refusal
Score Breakdown
Violation Severity
50.0×40%
Refusal Volume
69.9×30%
Recency
97.1×20%
Frequency
62.7×10%
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
328072×
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.
1184×
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2025 | 74MJNCATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/4/2025 | 74NIMSTENT, CAROTID | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/4/2025 | 74NIMSTENT, CAROTID | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 10/4/2013 | 74DWXSTRIPPER, ARTERY, INTRALUMINAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is MicroVention Costa Rica S.R.L.'s FDA import refusal history?
MicroVention Costa Rica S.R.L. (FEI: 3010079067) has 76 FDA import refusal record(s) in our database, spanning from 10/4/2013 to 11/17/2025.
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. MicroVention Costa Rica S.R.L.'s FEI number is 3010079067.
What types of violations has MicroVention Costa Rica S.R.L. received?
MicroVention Costa Rica S.R.L. has been cited for 2 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 MicroVention Costa Rica S.R.L. come from?
All FDA import refusal data for MicroVention Costa Rica S.R.L. 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.