Pleasanton, CA, United States
Thoratec Corp. recalls
15 recalls recorded since 2018, most recently on 13 May 2026. 12 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)12
Terminated or completed3
Class I (FDA)6
Ongoing Class II Medical devices
- Recall started
- 13 May 2026
- Reason
- Due to 11 volt Backup Battery failures.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the countries of Canada, Germany, Japan, Netherlands, Poland, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2519-2026, Z-2518-2026, Z-2520-2026
- Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communicat
- Brand 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
- Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Battery is a component
Ongoing Class II Medical devices
- Recall started
- 10 October 2025
- Reason
- Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
- Distribution
- Worldwide - US Nationwide distribution including in the states of MN, PA, OK, FL, CA, OR, IL, NY, DE, GA, NJ, NC, WI, OH, AZ, AR, TX, TN, MO, MA, MT, KY, NE, WV, VA, ME, ND, AL, CO, DC, MS, IN, MI, CT, SC, WA, NM, MD, HI, ID, IA, LA, UT, RI, NV and the countries of Algeria, Australia, Austria, Bahra
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1099-2026
- CentriMag 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;
Ongoing Class II Medical devices
- Recall started
- 9 October 2025
- Reason
- Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Algeria, Australia, Austria, Azerbaijan, Bahra
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0506-2026, Z-0508-2026, Z-0507-2026, Z-0505-2026
- Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller
- Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Con
- Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Seale
- Brand 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
Ongoing Class I Medical devices
- Recall started
- 23 June 2025
- Reason
- Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2290-2025, Z-2291-2025
- Brand 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 equipmen
- Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials
Ongoing Class I Medical devices
- Recall started
- 13 March 2025
- Reason
- Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
- Distribution
- Worldwide - US Nationwide distribution in the states of WA, NE, VA, PA, DC, KY, CA, IL, WI, TX, MA, AR, MS, MI, OH, FL, NC, TN, LA, NJ, UT, NY, DE, CT, GA, IN, AZ, OK, MO, OR, MN, SC, NM, MD, IA, KS, AL, CO, ME and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CZECH REPUBLIC,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1570-2025
- HeartMate 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.
Ongoing Class II Medical devices
- Recall started
- 25 June 2024
- Reason
- Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop
- Distribution
- US: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA, NE, CA, OK, CO, DC, IN, MI, CT, UT, IA, MD, OR, NM, ME, SC, KY, LA, WA, NV, HI, AL, MS, KS, WV. OUS: Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2583-2024
- HeartMate 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 L
Ongoing Class I Medical devices
- Recall started
- 8 May 2024
- Reason
- System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to initiate a command, which may lead to anxiety /inconvenience, hemodynamic compromise, extended surgical time, and Pump Stop command may be selected
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, BULGARIA, SWITZERLAND, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, EGYPT, SPAIN, FINLAND, FRANCE, UNITED KINGDOM, GUADELOUPE, GREECE, IRELAND, ISRAEL, IRAN, ISLAMIC REPUBLIC OF, ITALY, KUWAI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1921-2024
- Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
Ongoing Class I Medical devices
- Recall started
- 1 March 2024
- Reason
- Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
- Distribution
- Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WV; and OUS (foreign) countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Ca
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1692-2024, Z-1693-2024
- Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
- Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
Ongoing Class I Medical devices
- Recall started
- 19 February 2024
- Reason
- Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
- Distribution
- Worldwide distribution: U.S.(nationwide): AL,AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV; and O.U.S.(foreign) to countries of: Argentina, Australia, Austria, Bangladesh, Belgi
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1301-2024, Z-1300-2024
- HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief, US 3. HeartMate 3 S
- HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016
Ongoing Class I Medical devices
- Recall started
- 3 January 2024
- Reason
- Due to software and controller systems that results in unexpected pump start or pump stop.
- Distribution
- Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0842-2024
- 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a ta
Ongoing Class II Medical devices
- Recall started
- 7 August 2023
- Reason
- Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Can
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2658-2023
- Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Ongoing Class II Medical devices
- Recall started
- 22 October 2021
- Reason
- If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, IL, PA, AR, GA, WI, AZ, TN, TX, MA, NE, CA, VA, NC, OH, MI, DC, IN, NJ, CT, OK, MD, NY, ME, IA, SC, KY, LA, OR, NM, WA, SD, MO, NV, HI, AL, MS, UT, KS and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DE
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0308-2022
- Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Terminated Class II Medical devices
- Recall started
- 2 December 2019
- Terminated
- 14 September 2022
- Reason
- Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
- Distribution
- US Nationwide distribution in the states of MN, PA, IL, NJ, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, CO, OH, DE, FL, NY, IN, GA, VA, DC, CT, OK, UT, KY, MD, OR, NM, ME, SC, IA, WA, LA, NV, AL, KS, MS, WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0746-2020
- HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297
Terminated Class II Medical devices
- Recall started
- 30 March 2019
- Terminated
- 24 August 2020
- Reason
- Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak during the implant procedure.
- Distribution
- Worldwide distribution. US nationwide, Australia, Austria, Brazil, Canada, Cayman Islands, Chile, Colombia, Egypt, France, Germany, Greece, Singapore, Iran, Italy, Kuwait, Lebanon, Romania, Switzerland, Thailand, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2349-2019, Z-2348-2019
- Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 105581US/105581, RX only, Part of Left Ventricular Assist Device (LVAD) UDI: 00813024013266
- Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System
Terminated Class II Medical devices
- Recall started
- 1 March 2019
- Terminated
- 10 August 2022
- Reason
- Small black plastic particle was observed in the left ventricle during implant procedure.
- Distribution
- US Nationwide distribution in the states of MN, WI, TX, NC, GA, OK, UT, NY, SC, IL, LA, MI, IN, CA, OH, WA. Foreign (OUS): AUSTRIA, BELGIUM, CANADA, ESTONIA, FRANCE, GERMANY, GREECE, INDIA, ITALY, KUWAIT, LIECHTENSTEIN, LITHUANIA, NETHERLANDS, POLAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1203-2019
- Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.