Z-1607-2014 Class II Terminated
FDA device recall Z-1607-2014 was initiated by HeartWare Inc on Apr 16, 2014 and is designated Class II. Reason for recall: Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced. The recall status is terminated (terminated Oct 3, 2016). Affected quantity: 32,349.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- Apr 16, 2014
- Termination Date
- Oct 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,349
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.
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-1607-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026