Medtronic Neuromodulation FDA Record

Summary

FDA record by year

Medtronic Neuromodulation's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for Medtronic Neuromodulation above.

Medtronic Neuromodulation FDA Warning Letters

1 warning letter on Jul 17, 2012.

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent recalls

100 recall records from Nov 9, 2012 to Sep 8, 2026. Showing the 20 most recent. View all 100 recall records

Recent FDA inspections

15 inspections from Mar 24, 2009 to May 5, 2023.

NAI

No objectionable conditions or practices were found during the inspection.

VAI

Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

OAI

Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 2 compliance actions under Medtronic Neuromodulation: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Injunction, Apr 29, 2015.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Recent 510(k) clearances

1 510(k) clearance on Aug 23, 2021.

Medtronic Neuromodulation and the FDA: common questions

Has Medtronic Neuromodulation received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Medtronic Neuromodulation. The most recent is dated Jul 17, 2012.

Has Medtronic Neuromodulation received an FDA Form 483?

FDA has not published a Form 483 for "Medtronic Neuromodulation" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Medtronic Neuromodulation?

The most recent FDA inspection on file ended May 5, 2023 at Minneapolis, MN and was classified VAI. FDA has 15 inspections of Medtronic Neuromodulation on file, 2 of them classified OAI (official action indicated).

Has Medtronic Neuromodulation had an FDA recall?

Yes. Medtronic Neuromodulation has 100 FDA recalls on record, 14 of them Class I, the most serious class. The most recent under this name started Sep 8, 2026. A newer recall, dated Sep 24, 2026, is filed under the related name Medtronic.