Medtronic Inc
⚠️ High Risk
FEI: 1000442125 • Mounds View, MN • UNITED STATES
FEI
FEI Number
1000442125
📍
Location
Mounds View, MN
🇺🇸
Country
UNITED STATES🏢
Address
2240 Woodale Dr, , Mounds View, MN, United States
High Risk
FDA Import Risk Assessment
59.2
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
72
Total Refusals
4
Unique Violations
1/6/2007
Latest Refusal
5/3/2005
Earliest Refusal
Score Breakdown
Violation Severity
71.3×40%
Refusal Volume
69.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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
23752×
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).
50819×
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.
11818×
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).
3411×
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 |
|---|---|---|---|
| 1/6/2007 | 80LZGPUMP, INFUSION, INSULIN | 508NO 510(K) | San Francisco District Office (SAN-DO) |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 7/20/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | San Francisco District Office (SAN-DO) | |
| 5/5/2005 | 74NPTPROSTHESIS, AORTIC VALVE, PERCUTANEOUSLY DELIVERED | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Medtronic Inc's FDA import refusal history?
Medtronic Inc (FEI: 1000442125) has 72 FDA import refusal record(s) in our database, spanning from 5/3/2005 to 1/6/2007.
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. Medtronic Inc's FEI number is 1000442125.
What types of violations has Medtronic Inc received?
Medtronic Inc has been cited for 4 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 Medtronic Inc come from?
All FDA import refusal data for Medtronic Inc 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.