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Thoratec LLC FDA Recalls
12 recalls on file across devices, 3 of them Class I and 12 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US SoClass IIMay 13, 2026Due to 11 volt Backup Battery failures. |
| Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: Class IIMay 13, 2026Due to 11 volt Backup Battery failures. |
| Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: NClass IIMay 13, 2026Due to 11 volt Backup Battery failures. |
| CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag PreClass IIOct 10, 2025Acute circulatory support system pump may not fit into the m |
| Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeClass IIOct 9, 2025Due to potential corrosion issues associated with the Backup |
| Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 CoClass IIOct 9, 2025Due to potential corrosion issues associated with the Backup |
| Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Class IIOct 9, 2025Due to potential corrosion issues associated with the Backup |
| Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS KiClass IIOct 9, 2025Due to potential corrosion issues associated with the Backup |
| Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product DesClass IJun 23, 2025Due to misaligned V-Lock feature on the Mobile Power Unit po |
| Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: NClass IJun 23, 2025Due to misaligned V-Lock feature on the Mobile Power Unit po |
| HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HearClass IMar 13, 2025Left Ventricular Assist System Mobile Power Unit (MPU) may h |
| HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant KClass IIJun 25, 2024Left ventricular assist system controller UI membrane/screen |