Device establishmentActive, RegisteredFDA warning letter on file

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. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Dec 9, 2021

CGMP/QSR/Medical Devices/Adulterated

Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

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

Ongoing

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

Ongoing

Sep 12, 2025 Class II

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

Ongoing

Aug 6, 2025 Class I

The catheters may not retain their shape.

Ongoing

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.

Ongoing

Apr 16, 2024 Class II

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Ongoing

Mar 19, 2024 Class II

Potential for unsealed sterile packing.

Ongoing

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

Ongoing

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

Registration status

Active, Registered

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Feb 10, 2025 · Voluntary Action Indicated (VAI)
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)
Jun 4, 2014 · 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)

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; Investigation procedures; Evaluation of suppliers, contractors, etc., requirements

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?

Yes. FDA issued a warning letter to MEDTRONIC, INC.; the most recent is dated Dec 9, 2021 (CGMP/QSR/Medical Devices/Adulterated).

What does MEDTRONIC, INC. do?

MEDTRONIC, INC.'s FDA-registered operations are: Cardiovascular, Develop Specifications But Do Not Manufacture At This Facility.

Related facilities

Lewiston Feed & Produce Co. Inc.Bell International Laboratories, Inc BECKMAN COULTER, INC.

Source: FDA public data · status as of 2026-06-06