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U.S. Department of Health and Human Services

Class 2 Device Recall HeartMate 3 Left Ventricular Assist System

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  Class 2 Device Recall HeartMate 3 Left Ventricular Assist System see related information
Date Initiated by Firm December 02, 2019
Create Date December 27, 2019
Recall Status1 Terminated 3 on September 14, 2022
Recall Number Z-0746-2020
Recall Event ID 84379
PMA Number P160054 
Product Classification Ventricular (assist) bypass - Product Code DSQ
Product HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 107758, UDI or GTIN: 00813024010890, when connected to the HeartMate 3 Left Ventricular Assist System, REF 106524US, UDI or GTIN: 00813024013297, and 106524, UDI or GTIN: 00813024011712 - Product Usage: Provides power to the System Controller and pump. - Provides power to the System Monitor when it is connected to the Power Module. - Connects the System Monitor to the System Controller for monitoring purposes. - Echoes System Controller alarms. The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller.
Code Information 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		 Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or reduced blood flow from the left ventricular assist system.
FDA Determined
Cause 2		 Device Design
Action On 12/02/19, Urgent Medical Device Recall notices were delivered in person by field representatives who provided training on the methods to reduce generation of excessive static electricity. Clinician were advised the following: Recognition of alarms if the Left Ventricular Assist System (LVAS), when connected to the MPU Module, has been impacted by excessive static electricity. " If a patient is not sleeping or resting, battery power is recommended instead of the MPU Module to power the LVAS in order to reduce the impact of static electricity. " In any case of an unexpected "no external power" alarm, patients should connect to battery power to the LVAS before attempting to determine the cause of the alarm. If the alarm persists, the patient should call the Hospital Contact. " To prevent the generation of excessive static electricity during daily activities, the firm is providing clarification for static electricity management when using the MPU Module with the LVAS. Refer to Appendix A for specific reminders and recommendations to prevent excessive static electricity. Contact all patients with affected devices as soon as possible and provide them with the information in Appendix A. Also, please complete the attached acknowledgement form. Clarifications will be added to the Instructions for Use and Patient Handbook in the future. Customers with additional questions are encouraged to call 1-800-456-1477 or to contact their field representative. Using battery power will help avoid system damage from static electricity. If you're on the MPU, switch to battery power when doing things that cause static electricity. Reduce static electricity, with products such as: 1) A humidifier to add moisture to the air, 2) Dryer sheets and fabric softeners to reduce the buildup of static electricity in clothes and bedsheets, 3) Anti-static spray on carpets and other materials to reduce the buildup of static electricity 4) Skin moisturizers to make your skin less
Quantity in Commerce 13871
Distribution US Nationwide distribution in the states of MN, PA, IL, NJ, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, CO, OH, DE, FL, NY, IN, GA, VA, DC, CT, OK, UT, KY, MD, OR, NM, ME, SC, IA, WA, LA, NV, AL, KS, MS, WV.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Abbott Medical
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