HeartWare Ventricular Assist System recall
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory…
Why was HeartWare Ventricular Assist System recalled?
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101, 1102, 1104, 1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
- Product
- HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory…
- Recalling firm
- HeartWare Inc
- Quantity
- 3,747 currently in use
- Distribution
- 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, Foreign: 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, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK,
- Recall date
- June 17, 2015
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)