Thoratec LLC's Complete FDA Record

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Thoratec LLC 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.

Enforcement history

On 2026-06-24, Argus HQ recorded a FDA recall for Thoratec LLC, rated "high" severity in Argus HQ's classification: Thoratec LLC — Class II recall: Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS)… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-24, Argus HQ recorded a FDA recall for Thoratec LLC, rated "high" severity in Argus HQ's classification: Thoratec LLC — Class II recall: Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Ca… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-24, Argus HQ recorded a FDA recall for Thoratec LLC, rated "high" severity in Argus HQ's classification: Thoratec LLC — Class II recall: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catal… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Thoratec LLC has 3 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). 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

Does Argus HQ track new FDA actions for Thoratec 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 Thoratec LLC is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Thoratec LLC?

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 Thoratec LLC?

June 24, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Thoratec LLC had product recalls?

Yes, 3 recalls on file. See the full history below for each one.

Related enforcement actions

• Thoratec LLC — Class II recall: Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Ca… →
• Thoratec LLC — Class II recall: Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catal… →
• Thoratec LLC — Class II recall: Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS)… →

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