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THORATEC HEARTMATE, SYSTEM MONITOR recallZ-1921-2024 · Thoratec Corp. · initiated May 8, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Thoratec Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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 [email protected] If you have any questions about this communication, please contact your local firm representative or Technical Support at 1-800-456-1477.

Recall details

Recall number
Z-1921-2024
Status
Open, Classified
Initiated by the company
May 8, 2024
Posted by the FDA
Jun 7, 2024
Recalling firm
Thoratec Corp.
Quantity
4,842
Product code
DSQ
FDA submissions
P160054, P060040
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, 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

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

Code information (models, lots, serial numbers)

UDI-DI: 00813024010142, 00813024010852. All Serial Numbers

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

25 devices cleared under P160054, P060040 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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