Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reported: August 7, 2013 Initiated: May 16, 2013 #Z-1813-2013
Product Description
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason for Recall
Potential to electrostatic discharged (ESD)
Details
- Recalling Firm
- HeartWare Inc
- Units Affected
- 76 (US) and 82 (International)
- Distribution
- Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device). Recalled by HeartWare Inc. Units affected: 76 (US) and 82 (International).
Why was this product recalled? ▼
Potential to electrostatic discharged (ESD)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2013. Severity: Moderate. Recall number: Z-1813-2013.
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