Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Recall
- Recall Number
- Z-1632-2016
- Event Number
- 73837
- Firm
- St Jude Medical Inc.
- FEI Number
- 2017865
- Product Code
- LWS
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 31, 2016
- Terminated
- June 29, 2016
- Address
- 15900 Valley View Ct, Sylmar, CA, 91342-3577
Description
Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.
A customer letter dated 4/7/16 was sent to all customers to inform them that St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy. The letter informs the customers that the recall involves information related to 127 units of our Ellipse ICD device distributed worldwide but not implanted in patients. Customers with any questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at 800-722-3774, 24 hours a day, seven days a week.
Worldwide Distribution - US Nationwide in the states of CT, NJ, SC, FL, GA and countries of: Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam.
127 units