Z-1731-2015 Class I Ongoing
FDA device recall Z-1731-2015 was initiated by HeartWare Inc on Apr 29, 2015 and is designated Class I. Reason for recall: Complaints with the HVAD Internal Controller Alarm Battery failures. The recall status is ongoing. Affected quantity: 3,747 curently implanted.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 24, 2015
- Initiation Date
- Apr 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,747 curently implanted
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution -- US, including 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, and VA; and, the 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-1731-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026