Z-0005-2017 Class I Terminated
FDA device recall Z-0005-2017 was initiated by Heartware, Inc. on Jun 8, 2016 and is designated Class I. Reason for recall: Loose connector ports in controller body. The recall status is terminated (terminated Mar 31, 2020). Affected quantity: 4235 Worldwide, 7272 units in U.S.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 26, 2016
- Initiation Date
- Jun 8, 2016
- Termination Date
- Mar 31, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4235 Worldwide, 7272 units in U.S.
Product Description
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Reason for Recall
Loose connector ports in controller body.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.
Code Information
All Heartware Controllers manufactured after September 2014. US Model No: 1400, 1401XX, 1403US. International Model No: 1400, 1401XX, 1407XX.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0005-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026