Z-1887-2016 Class I Terminated
FDA device recall Z-1887-2016 was initiated by Heartware, Inc. on Jan 7, 2016 and is designated Class I. Reason for recall: Heartware Ventricular Assist System Battery Cell experiencing premature depletion. The recall status is terminated (terminated Mar 27, 2020). Affected quantity: 18, 631.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 20, 2016
- Initiation Date
- Jan 7, 2016
- Termination Date
- Mar 27, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18, 631
Product Description
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.
Reason for Recall
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
Distribution Pattern
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.
Code Information
Serial numbers ranging BAT000001 to BAT199999.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1887-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026