Z-1131-2015 Class I Terminated
FDA device recall Z-1131-2015 was initiated by HeartWare Inc on Jan 16, 2015 and is designated Class I. Reason for recall: The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers. The recall status is terminated (terminated Feb 5, 2020). Affected quantity: 4,845.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 4, 2015
- Initiation Date
- Jan 16, 2015
- Termination Date
- Feb 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,845
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canada, Poland, Australia, Austria, Italy, DE, New Zealand, South Africa, France, Switzerland, Germany, Brazil, UK, Belgium, Netherlands, Israel, Malaysia, Turkey, Greece, Japan, Singapore, Poland, Lithuania, Sweden, Norway, Finland, and India.
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-1131-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026