Recall Register

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Thoratec LLC

FDA recalling firm · 6 enforcement events · 12 product records · 2024–2026 · CA

Thoratec LLC has 6 FDA enforcement events on this register (12 product records) between 2024 and 2026: 6 device; the busiest year was 2025 with 4.

33% of its events are Class I; the most common class is Class II (4). 6 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
13 May 2026Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide…DeviceClass II3Ongoing
10 Oct 2025CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood…DeviceClass II1Ongoing
9 Oct 2025Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and…DeviceClass II4Ongoing
23 Jun 2025Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to…DeviceClass I2Ongoing
13 Mar 2025HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.DeviceClass I1Ongoing
25 Jun 2024HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3…DeviceClass II1Ongoing

By type and class

Device6
Class II4
Class I2

Class I: 33% of this firm's events; 18% of all events on the register.

Events by year

24
25
26
Enforcement events for Thoratec LLC by year initiated.

Questions and answers

How many FDA recalls has Thoratec LLC had?

6 enforcement events (12 product records) on this register, 2024–2026: 6 device.

Are any Thoratec LLC recalls ongoing?

6 events are listed as ongoing in the current openFDA export.

What class are Thoratec LLC recalls?

4 Class II, 2 Class I. 33% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.