Heartware HVAD Pump Implant Kit recall
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
Why was Heartware HVAD Pump Implant Kit recalled?
HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675
- Product
- Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
- Recalling firm
- Heartware Inc
- Quantity
- 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.
- Recall date
- May 22, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)