Recall Z-1632-2016— St Jude Medical Inc.
Class II · Terminated
Class II FDA medical device recall by St Jude Medical Inc., initiated 2016-03-31, terminated 2016-06-29. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy..
- Recalling firm
- St Jude Medical Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-31
- Terminated
- 2016-06-29
- Firm location
- Sylmar, CA, United States
Product 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.
Reason for recall
St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.