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Recall Observatory FDA recall evidence

Device product

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

Z-1323-2013

December 27, 2012

Class II

Product summary

Firm
Heartware Inc
Event
Event 64390
Status
Terminated
Classification
Class II
Quantity
3,544
Official record key
device-enforcement:Z-1323-2013

Official wording

Reason: HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.

Code information: Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.