Z-0006-2017 Class I Ongoing
FDA device recall Z-0006-2017 was initiated by HeartWare, Inc on Aug 17, 2016 and is designated Class I. Reason for recall: Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults. The recall status is ongoing. Affected quantity: 344 pumps.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 19, 2016
- Initiation Date
- Aug 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 344 pumps
Product Description
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for Recall
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Distribution Pattern
Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.
Code Information
All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0006-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026