Z-1813-2013 Class II Terminated
FDA device recall Z-1813-2013 was initiated by HeartWare Inc on May 16, 2013 and is designated Class II. Reason for recall: Potential to electrostatic discharged (ESD) The recall status is terminated (terminated Aug 5, 2019). Affected quantity: 76 (US) and 82 (International).
Recall Details
- Product Type
- Devices
- Report Date
- Aug 7, 2013
- Initiation Date
- May 16, 2013
- Termination Date
- Aug 5, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 76 (US) and 82 (International)
Product Description
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason for Recall
Potential to electrostatic discharged (ESD)
Distribution Pattern
Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Code Information
US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1813-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026