Regulatory Record: Edwards Lifesciences, LLC

FDA action counts

Enforcement history

On 2026-05-20, Argus HQ recorded an FDA recall for Edwards Lifesciences, LLC, rated "high" severity in Argus HQ's classification: Edwards Lifesciences, LLC — Class II recall: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO. 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. Edwards Lifesciences, LLC 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.

Frequently asked questions

What is the most recent FDA action against Edwards Lifesciences, LLC?

The most recent FDA event Argus HQ has on file for Edwards Lifesciences, LLC is dated 2026-05-20, 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 Edwards Lifesciences, LLC 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 Edwards Lifesciences, LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Edwards Lifesciences, LLC?

17 total: 0 warning letters, 17 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Edwards Lifesciences, LLC?

May 20, 2026. Argus HQ ingests new FDA enforcement records daily.

Related enforcement actions

• Edwards Lifesciences, LLC — Class II recall: Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO →
• Edwards Lifesciences, LLC — Class I recall: Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N… →
• Edwards Lifesciences, LLC — Class I recall: Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Nu… →
• Edwards Lifesciences, LLC — Class I recall: Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N… →
• Edwards Lifesciences, LLC — Class I recall: Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N… →
• Edwards Lifesciences, LLC — Class I recall: Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula… →
• Edwards Lifesciences, LLC — Class I recall: Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula… →
• Edwards Lifesciences, LLC — Class II recall: Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only.… →
• Edwards Lifesciences, LLC — Class II recall: TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in… →
• Edwards Lifesciences, LLC — Class II recall: FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx on… →

Compare with

• Edwards Lifesciences, LLC vs Philips North America
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• Edwards Lifesciences, LLC vs PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.