Heartware Inc: Medical Device Recall in 2013 - (Recall #: Z-1323-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

Product Classification:

Class II

Date Initiated: December 27, 2012

Date Posted: May 22, 2013

Recall Number: Z-1323-2013

Event ID: 64390

Reason for Recall:

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

Status: Terminated

Product Quantity: 3,544

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.

Voluntary or Mandated:

Voluntary: Firm initiated