HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
Reported: June 24, 2015 Initiated: April 29, 2015 #Z-1731-2015
Product Description
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
Reason for Recall
Complaints with the HVAD Internal Controller Alarm Battery failures.
Details
- Recalling Firm
- HeartWare Inc
- Units Affected
- 3,747 curently implanted
- Distribution
- 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.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.. Recalled by HeartWare Inc. Units affected: 3,747 curently implanted.
Why was this product recalled? ▼
Complaints with the HVAD Internal Controller Alarm Battery failures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2015. Severity: Critical. Recall number: Z-1731-2015.
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