Z-1323-2013 Class II Terminated
FDA device recall Z-1323-2013 was initiated by Heartware Inc on Dec 27, 2012 and is designated Class II. 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. The recall status is terminated (terminated Jul 9, 2013). Affected quantity: 3,544.
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2013
- Initiation Date
- Dec 27, 2012
- Termination Date
- Jul 9, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,544
Product Description
Reason for Recall
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.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1323-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026