Regulatory Record: Maquet Cardiopulmonary Gmbh

FDA action counts

Enforcement history

On 2026-09-23, Argus HQ recorded an FDA recall for Maquet Cardiopulmonary Gmbh, rated "high" severity in Argus HQ's classification: Maquet Cardiopulmonary Gmbh — Class II recall: Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (US…. On 2026-09-23, Argus HQ recorded an FDA recall for Maquet Cardiopulmonary Gmbh, rated "high" severity in Argus HQ's classification: Maquet Cardiopulmonary Gmbh — Class II recall: Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA),…. On 2026-09-23, Argus HQ recorded an FDA recall for Maquet Cardiopulmonary Gmbh, rated "high" severity in Argus HQ's classification: Maquet Cardiopulmonary Gmbh — Class II recall: Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (US…. 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.

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Maquet Cardiopulmonary Gmbh has 3 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

What is the most recent FDA action against Maquet Cardiopulmonary Gmbh?

The most recent FDA event Argus HQ has on file for Maquet Cardiopulmonary Gmbh is dated 2026-09-23, 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 Maquet Cardiopulmonary Gmbh 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 Maquet Cardiopulmonary Gmbh is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Maquet Cardiopulmonary Gmbh?

3 total: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Maquet Cardiopulmonary Gmbh?

September 23, 2026. Argus HQ ingests new FDA enforcement records daily.

Related enforcement actions

• Maquet Cardiopulmonary Gmbh — Class II recall: Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (US… →
• Maquet Cardiopulmonary Gmbh — Class II recall: Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA),… →
• Maquet Cardiopulmonary Gmbh — Class II recall: Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (US… →

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