Thoratec Corp.: Medical Device Recall in 2024 - (Recall #: Z-1921-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: May 8, 2024

Date Posted: June 19, 2024

Recall Number: Z-1921-2024

Event ID: 94478

Reason for Recall:

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

Status: Ongoing

Product Quantity: 4,842

Code Information:

UDI-DI: 00813024010142, 00813024010852. All Serial Numbers

Distribution Pattern:

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, KUWAIT, LEBANON, LITHUANIA, LUXEMBOURG, MACEDONIA, MARTINIQUE, NETHERLANDS, NORWAY, OMAN, POLAND, PALESTINE, PORTUGAL, QATAR, ROMANIA, SERBIA, RUSSIAN FEDERATION, SWEDEN, SLOVENIA, TUNISIA, TURKEY, SOUTH AFRICA, CANADA, AUSTRALIA, HONG KONG, MALAYSIA, SINGAPORE, SOUTH KOREA, TAIWAN, THAILAND, JAPAN, BANGLADESH, INDIA, PAKISTAN, ARGENTINA, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, MEXICO, and BRAZIL

Voluntary or Mandated:

Voluntary: Firm initiated