FDA Actions Against Stryker Neurovascular

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Stryker Neurovascular has 1 FDA event on file. 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.

Enforcement history

On 2026-07-01, Argus HQ recorded an FDA recall for Stryker Neurovascular, rated "high" severity in Argus HQ's classification: Stryker Neurovascular — Class II recall: INZONE DETACHMENT SYSTEM, REF: M00345100950. 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. 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.

Frequently asked questions

Is this FDA enforcement data for Stryker Neurovascular 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 Stryker Neurovascular had?

Argus HQ has recorded 1 FDA events for Stryker Neurovascular: 0 warning letters, 1 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 Stryker Neurovascular?

The most recent FDA event Argus HQ has on file for Stryker Neurovascular is dated 2026-07-01, with a severity rating of "high" 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.

Does Argus HQ track new FDA actions for Stryker Neurovascular automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Stryker Neurovascular is observed, this page's event count and history update automatically.

Related enforcement actions

• Stryker Neurovascular — Class II recall: INZONE DETACHMENT SYSTEM, REF: M00345100950 →
• Stryker Neurovascular — Class II recall: The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiff… →
• Stryker Neurovascular — Class II recall: The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip an… →
• Stryker Neurovascular — Class II recall: The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable… →
• Stryker Neurovascular — Class II recall: The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable t… →
• Stryker Neurovascular — Class II recall: DAC 044 115cm, Catalog: 90760 →
• Stryker Neurovascular — Class II recall: Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x… →
• Stryker Neurovascular — Class II recall: FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495 →
• Stryker Neurovascular — Class II recall: Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PA… →
• Stryker Neurovascular — Class II recall: Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog… →

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• Stryker Neurovascular vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.