Thoratec LLC

Complete recall history across all FDA and CPSC categories — 9 total recalls

Thoratec LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (9)

FDA medical device enforcement actions by Thoratec LLC

Date Product Reason Class
Oct 10, 2025 CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMa... Acute circulatory support system pump may not fit into the motor and reports ... Class II
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... Due to potential corrosion issues associated with the Backup Battery cable co... Class II
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Ca... Due to potential corrosion issues associated with the Backup Battery cable co... Class II
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) M... Due to potential corrosion issues associated with the Backup Battery cable co... Class II
Oct 9, 2025 Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Mod... Due to potential corrosion issues associated with the Backup Battery cable co... Class II
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number:... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which ... Class I
Jun 23, 2025 Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/... Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which ... Class I
Mar 13, 2025 HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 10775... Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical co... Class I
Jun 25, 2024 HeartMate 3 System Controllers provided within the following HeartMate 3 Left... Left ventricular assist system controller UI membrane/screen may lift along t... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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