Medtronic B.V.
⚠️ Moderate Risk
FEI: 3002807561 • Heerlen, Limburg • NETHERLANDS
FEI Number
3002807561
Location
Heerlen, Limburg
Country
NETHERLANDSAddress
Earl Bakkenstraat 10, Postbus 2580n, Heerlen, Limburg, Netherlands
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2023 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2023 | 80LZGPUMP, INFUSION, INSULIN | Division of Southeast Imports (DSEI) | |
| 10/15/2013 | 74DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | Florida District Office (FLA-DO) | |
| 8/21/2012 | 74NVNPACEMAKER ELECTRODE, PERMANENT, DRUG-ELUTING | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/21/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/6/2012 | 74DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/6/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/6/2012 | 74NVNPACEMAKER ELECTRODE, PERMANENT, DRUG-ELUTING | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/16/2012 | 74NVNPACEMAKER ELECTRODE, PERMANENT, DRUG-ELUTING | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/16/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/22/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | Florida District Office (FLA-DO) | |
| 3/22/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | Florida District Office (FLA-DO) | |
| 3/14/2012 | 74NVNPACEMAKER ELECTRODE, PERMANENT, DRUG-ELUTING | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/14/2012 | 74DRFCATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/8/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/8/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 2/21/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | Florida District Office (FLA-DO) | |
| 2/21/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | Florida District Office (FLA-DO) | |
| 2/21/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | Florida District Office (FLA-DO) | |
| 1/30/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 1/19/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 1/17/2012 | 74DXYPULSE-GENERATOR, PACEMAKER, IMPLANTABLE | Florida District Office (FLA-DO) | |
| 10/1/2009 | 87MOOORTHOPEDIC IMPLANT MATERIAL | Division of Southeast Imports (DSEI) | |
| 5/3/2005 | 74MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | 237NO PMA | San Francisco District Office (SAN-DO) |
| 6/24/2003 | 74DTBELECTRODE, PACEMAKER, PERMANENT | Minneapolis District Office (MIN-DO) | |
| 12/3/2002 | 74MIEHEART-VALVE, ALLOGRAFT | Los Angeles District Office (LOS-DO) | |
| 2/8/2002 | 74DYEHEART-VALVE, REPLACEMENT | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Medtronic B.V.'s FDA import refusal history?
Medtronic B.V. (FEI: 3002807561) has 27 FDA import refusal record(s) in our database, spanning from 2/8/2002 to 12/22/2023.
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 B.V.'s FEI number is 3002807561.
What types of violations has Medtronic B.V. received?
Medtronic B.V. 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 Medtronic B.V. come from?
All FDA import refusal data for Medtronic B.V. 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.