Thoratec LLC: Device Recall

Recall Details

Recall Number

Z-2583-2024

Classification

Class II

Product Type

Device

Recalling Firm

Thoratec LLC

Status

Ongoing

Date Initiated

06/25/2024

Location

Pleasanton, CA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

694

Reason for Recall

Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop

Product Description

HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3 System Controller, OUS, Model: 106531INT; HeartMate 3 System Controller Low Flow 2.0, Global, Model: 106531LF2

Distribution Pattern

US: MN, PA, FL, IL, NY, DE, AR, NJ, NC, GA, WI, AZ, TN, MO, TX, MA, OH, VA, NE, CA, OK, CO, DC, IN, MI, CT, UT, IA, MD, OR, NM, ME, SC, KY, LA, WA, NV, HI, AL, MS, KS, WV. OUS: Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzegovina, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Morocco, Netherlands, New Zealand, Norway, Oman, Palestine, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan

Other Recalls by Thoratec LLC

• Class II: Risk 10/10/2025
  Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.
• Class II: Risk 10/09/2025
  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
• Class II: Risk 10/09/2025
  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
• Class II: Risk 10/09/2025
  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
• Class II: Risk 10/09/2025
  Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.

View all recalls by Thoratec LLC →