Z-1227-2014 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2014
- Initiation Date
- March 4, 2014
- Termination Date
- August 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1737 catalog number 106015; 609 catalog number 106016
Product Description
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Reason for Recall
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Distribution Pattern
Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, 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: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.
Code Information
Catalog number 106015 (NAm) 106016 - EU all serial numbers