HeartWare Ventricular Assist System Controller Product recall
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from…
Why was HeartWare Ventricular Assist System Controller Product recalled?
Loose connector ports in controller body.
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?
All Heartware Controllers manufactured after September 2014. US Model No: 1400, 1401XX, 1403US. International Model No: 1400, 1401XX, 1407XX.
- Product
- HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from…
- Recalling firm
- Heartware, Inc.
- Quantity
- 4235 Worldwide, 7272 units in U.S.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.
- Recall date
- October 26, 2016
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)