Thoratec LLC: Device Recall

Recall Details

Recall Number

Z-0506-2026

Classification

Class II

Product Type

Device

Recalling Firm

Thoratec LLC

Status

Ongoing

Date Initiated

10/09/2025

Location

Pleasanton, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

35376

Reason for Recall

Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

Product Description

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 Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 LVAS

Distribution Pattern

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, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, Uzbekistan.

Other Recalls by Thoratec LLC

• Class II: Risk 10/10/2025
  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.
• Class II: Risk 10/09/2025
  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
• Class II: Risk 10/09/2025
  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
• Class II: Risk 10/09/2025
  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
• Class I: Dangerous 06/23/2025
  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.

View all recalls by Thoratec LLC →