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U.S. Department of Health and Human Services

Class 1 Device Recall HeartMate System Monitor

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  Class 1 Device Recall HeartMate System Monitor see related information
Date Initiated by Firm May 08, 2024
Date Posted June 07, 2024
Recall Status1 Open3, Classified
Recall Number Z-1921-2024
Recall Event ID 94478
PMA Number P160054 P060040 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product 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 UDI-DI: 00813024010142, 00813024010852. All Serial Numbers
Recalling Firm/
Manufacturer
Thoratec Corp.
6035 Stoneridge Dr
Pleasanton CA 94588-3270
For Additional Information Contact Justin Paquette
651-756-6293
Manufacturer 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
FDA Determined
Cause 2
Device Design
Action 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.
Quantity in Commerce 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, 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Abbott Medical
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