Z-1921-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2024
- Initiation Date
- May 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,842
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
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
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
Code Information
UDI-DI: 00813024010142, 00813024010852. All Serial Numbers