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Terminated

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.

FDA Recall Z-1632-2016 · Posted None

Recalling FirmSt Jude Medical Inc.
Recall StatusTerminated
Product CodeLWS
Date Initiated2016-03-31
Date Terminated2016-06-29
Product Quantity127 units

Reason for Recall

St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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