Thoratec LLC: Device Recall

Recall Details

Recall Number

Z-1570-2025

Classification

Class I

Product Type

Device

Recalling Firm

Thoratec LLC

Status

Ongoing

Date Initiated

03/13/2025

Location

Pleasanton, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1661

Reason for Recall

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.

Product Description

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.

Distribution Pattern

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, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, ISRAEL, ITALY, JAPAN, KUWAIT, LEBANON, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, ROMANIA, SERBIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UK, UNITED ARAB EMIRATES.

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 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.

View all recalls by Thoratec LLC →