Recall Z-0746-2020 ยท DSQ Ventricular (Assist) Bypass
Thoratec Corp.
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 Powe
| Date | Dec 2, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 p |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.