Z-1471-2014 Class I Terminated
FDA device recall Z-1471-2014 was initiated by HeartWare Inc on Dec 6, 2013 and is designated Class I. Reason for recall: The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector. The recall status is terminated (terminated Nov 3, 2016). Affected quantity: 4,586.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 30, 2014
- Initiation Date
- Dec 6, 2013
- Termination Date
- Nov 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,586
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey and United Kingdom.
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-1471-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026