FDAFDA · Food and drugs·Recall number Z-1632-2016
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.
Published May 18, 2016 · Recall initiated: March 31, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St Jude Medical Inc.
- Distributor
- 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.
- Lot
- Serial No. 7263877 7263892 7263900 7263904 7264199 7265399 7265400 7265401 7263916 7264214 7264398 7265581
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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