Z-1538-2017 Class I Ongoing
FDA device recall Z-1538-2017 was initiated by Heartware on February 3, 2017 and is designated Class I. Reason for recall: Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0) The recall status is ongoing. Affected quantity: 8,343 US and 13,145 INTERNATIONAL.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2017
- Initiation Date
- February 3, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,343 US and 13,145 INTERNATIONAL
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, 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 Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, , Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, UK, and Vietnam.