Z-1698-2015 Class I Ongoing
FDA device recall Z-1698-2015 was initiated by HeartWare Inc on Apr 29, 2015 and is designated Class I. Reason for recall: HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller. The recall status is ongoing. Affected quantity: 3,747 currently implanted worldwide.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 17, 2015
- Initiation Date
- Apr 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,747 currently implanted worldwide
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
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-1698-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026