Has Medtronic Neurosurgery had product recalls?

Yes, 9 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Medtronic Neurosurgery official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Medtronic Neurosurgery had?

Argus HQ has recorded 9 FDA events for Medtronic Neurosurgery: 0 warning letters, 9 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Medtronic Neurosurgery?

The most recent FDA event Argus HQ has on file for Medtronic Neurosurgery is dated 2024-12-25, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Medtronic Neurosurgery — FDA Enforcement History

FDA action counts

Total FDA actions	9
Warning letters	0
Recalls	9
Approval records	0
Form 483 inspection citations	0
Most recent action	December 25, 2024

The short version: Argus HQ has recorded 9 FDA events for Medtronic Neurosurgery: 0 warning letters, 9 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-07-26 to 2024-12-25. The most severe rating Argus HQ has assigned across this history is "critical". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Enforcement history

On 2024-12-25, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "critical" severity in Argus HQ's classification: Medtronic Neurosurgery — Class I recall: Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SI…. On 2024-12-25, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "critical" severity in Argus HQ's classification: Medtronic Neurosurgery — Class I recall: Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VC…. On 2024-03-06, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "critical" severity in Argus HQ's classification: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site…. On 2024-03-06, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "critical" severity in Argus HQ's classification: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site…. On 2024-03-06, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "critical" severity in Argus HQ's classification: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Site…. On 2024-03-06, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "critical" severity in Argus HQ's classification: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sit…. On 2024-03-06, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "critical" severity in Argus HQ's classification: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site…. On 2023-08-23, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "high" severity in Argus HQ's classification: Medtronic Neurosurgery — Class II recall: Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Inje…. On 2023-07-26, Argus HQ recorded an FDA recall for Medtronic Neurosurgery, rated "high" severity in Argus HQ's classification: Medtronic Neurosurgery — Class II recall: Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUR….

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Medtronic Neurosurgery has 9 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Frequently asked questions

Has Medtronic Neurosurgery had product recalls?: Yes, 9 recalls on file. See the full history below for each one.
Is this FDA enforcement data for Medtronic Neurosurgery official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has Medtronic Neurosurgery had?: Argus HQ has recorded 9 FDA events for Medtronic Neurosurgery: 0 warning letters, 9 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against Medtronic Neurosurgery?: The most recent FDA event Argus HQ has on file for Medtronic Neurosurgery is dated 2024-12-25, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

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Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Verified from FDA.gov · Last updated: Dec 25, 2024

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2024). Medtronic Neurosurgery — FDA Enforcement History. Digital Empire LLC. Retrieved from https://argushq.ai/company/medtronic-neurosurgery

MLA

"Medtronic Neurosurgery — FDA Enforcement History." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/company/medtronic-neurosurgery.

Chicago

Argus HQ Research. "Medtronic Neurosurgery — FDA Enforcement History." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/medtronic-neurosurgery.

BibTeX

@misc{argushq_argushq_ai_company_medtronic_neurosurgery_2024,
  title = {Medtronic Neurosurgery — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2024},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/medtronic-neurosurgery},
  note = {Accessed: July 17, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗