Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reported: May 22, 2013 Initiated: December 27, 2012 #Z-1323-2013
Product Description
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Reason for Recall
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Details
- Recalling Firm
- Heartware Inc
- Units Affected
- 3,544
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.
- 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: 3,544.
Why was this product recalled? ▼
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2013. Severity: Moderate. Recall number: Z-1323-2013.
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