device · product 1 of 1
HeartWare Ventricular Assist System (HeartWare Controller) 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. The HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
- Recall number
- Z-1131-2015
- Initiated
- January 16, 2015
- Classification
- Class I
- Status
- Terminated
- Recalling firm
- HeartWare Inc
- Quantity
- 4,845
App-derived interpretation
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Code information
Product Codes- US product: Model No.: 1400, 1401US; International product: Model No.: 1400, 1401XX ('XX' represents country designation) Serial No.: CON000001 through CON005472
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.