Thoratec Corp.: 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

Hazard

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

Details from the source

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: 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 Quantity: 4,842 Lot/code info: UDI-DI: 00813024010142, 00813024010852. All Serial Numbers

UPC codes

00813024010142, 00813024010852

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.