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Device establishmentActive, RegisteredOfficial Action Indicated

MEDTRONIC, INC.

MEDTRONIC, INC. is an FDA-registered device establishment (FEI 2182208) located in Mounds View, Minnesota. The facility is active, registered. Its most recent FDA inspection on record (2025-02-10) was classified VAI.

Recalls (8)

Feb 13, 2026 Class II
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered
OngoingView source data ›
Nov 20, 2025 Class II
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of u
OngoingView source data ›
Sep 12, 2025 Class II
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
OngoingView source data ›
Aug 6, 2025 Class I
The catheters may not retain their shape.
OngoingView source data ›
May 7, 2025 Class II
The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
OngoingView source data ›
Apr 16, 2024 Class II
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
OngoingView source data ›
Mar 19, 2024 Class II
Potential for unsealed sterile packing.
OngoingView source data ›
Sep 26, 2023 Class II
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, b
OngoingView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
2182208
Address
8200 Coral Sea Street NE, Mounds View, Minnesota
Establishment type
Device establishment
Products / operations
Cardiovascular, Develop Specifications But Do Not Manufacture At This Facility, Unknown, Manufacture Medical Device, Repack or Relabel Medical Device, General, Plastic Surgery, General Hospital, Manufacture Device in the United States for Export Only
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Feb 10, 2025 · Voluntary Action Indicated (VAI)
Sep 1, 2023 · No Action Indicated (NAI)
Feb 4, 2020 · Voluntary Action Indicated (VAI)
May 14, 2018 · Official Action Indicated (OAI)
Aug 30, 2017 · No Action Indicated (NAI)
Feb 29, 2016 · No Action Indicated (NAI)
Oct 31, 2013 · No Action Indicated (NAI)
Sep 25, 2013 · No Action Indicated (NAI)
Jul 16, 2013 · No Action Indicated (NAI)
Jan 30, 2012 · No Action Indicated (NAI)
Nov 30, 2010 · Voluntary Action Indicated (VAI)
Sep 2, 2010 · Voluntary Action Indicated (VAI)
Form 483 observations
Feb 10, 2025, 1 observation: Documentation
May 14, 2018, 3 observations: Lack of or inadequate procedures; Design transfer - Lack of or inadequate procedures; Production and Process Change Procedures, lack of or Inad.
Sep 2, 2010, 2 observations: Purchasing controls, Lack of or inadequate procedures; Lack of or inadequate procedures
Aug 6, 2009, 8 observations: Procedures; Design changes - Lack of or Inadequate Procedures; Individual Report of Malfunction

FDA record timeline

Recall
Class II — All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered
Source ›
Recall
Class II — Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of u
Source ›
Recall
Class II — Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Source ›
Recall
Class I — The catheters may not retain their shape.
Source ›
Recall
Class II — The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
Source ›
FDA inspection
VAI classification
Form 483
1 observation
Recall
Class II — Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Source ›
Recall
Class II — Potential for unsealed sterile packing.
Source ›
Recall
Class II — Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, b
Source ›
FDA inspection
NAI classification
FDA inspection
VAI classification
FDA inspection
OAI classification
Form 483
3 observations
FDA inspection
NAI classification
FDA inspection
NAI classification

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is MEDTRONIC, INC. registered with the FDA?

Yes. MEDTRONIC, INC. is an FDA-registered device establishment (FEI 2182208) in Mounds View, Minnesota. Its current registration status is Active, Registered.

Has MEDTRONIC, INC. received an FDA warning letter?

FDA has not posted a warning letter for MEDTRONIC, INC.. FDA publishes only a subset of enforcement records, so this is not a guarantee.

What does MEDTRONIC, INC. do?

MEDTRONIC, INC.'s FDA-registered operations are: Cardiovascular, Develop Specifications But Do Not Manufacture At This Facility, Unknown, Manufacture Medical Device, Repack or Relabel Medical Device, General, Plastic Surgery, General Hospital, Manufacture Device in the United States for Export Only.

Related facilities

Lewiston Feed & Produce Co. Inc.Bell International Laboratories, IncCellEra, LLCBECKMAN COULTER, INC.Phillips Precision IncTESLA BIOHEALING, INC.

Source: FDA public data · status as of 2026-08-22

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