Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN

FDA device recall Z-1921-2024 · posted 2024-06-07 · Open, Classified

Recall details

Recalling firm

Thoratec Corp.

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

Action taken

On 5/8/24, Abbott Medical distributed correction notices to customers who were asked to do the following: All System Monitors can potentially show atypical screen display behaviors. Restarting the System Monitor should resolve these issues in most cases. Clinician Guidance Firm is advising clinicians to restart the System Monitor unit before connecting to the Controller, if the unit has been running for a long period of time, or if screen issues are observed. To restart the unit, turn off and then turn on using the On/Off Switch located on the back of the System Monitor. It takes approximately 10 seconds to fully restart and display the information on the screen. If the unit is restarted while connected to the patient s Controller the LVAD settings will remain the same. Upon System Monitor restart, if the screen display issues continue, check that all cables and connections are secure and undamaged. If the atypical screen issues persist, use a different System Monitor. If the "Stop Pump" button is inadvertently pressed, the pump will stop momentarily and restart. If, however, the pump stop button is pressed longer than ten seconds, the pump will stop and the Controller will alarm "Pump Off Alarm". To resolve the "Pump Off Alarm" and restart the pump, clinicians can press any button on the Controller to attempt pump start as instructed in the Instructions for Use. Distribute this notice to those who need to be aware within your institution and forward to any institution where potentially affected devices have been transferred. Complete and return the acknowledgement form via email to MCSHMNotices@Abbott.com If you have any questions about this communication, please contact your local firm representative or Technical Support at 1-800-456-1477.

Root cause

Device Design

Status

Open, Classified

Product code

DSQ

Quantity affected

4,842

Distribution

Worldwide distribution. US nationwide including Puerto Rico, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, BULGARIA, SWITZERLAND, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, EGYPT, SPAIN, FINLAND, FR

Date initiated

2024-05-08

Date posted

2024-06-07

Location

Pleasanton, CA