St Jude Medical Inc.: Medical Device Recall in 2016 - (Recall #: Z-1632-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 31, 2016

Date Posted: May 18, 2016

Recall Number: Z-1632-2016

Event ID: 73837

Reason for Recall:

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

Status: Terminated

Product Quantity: 127 units

Code Information:

Serial No. 7263877 7263892 7263900 7263904 7264199 7265399 7265400 7265401 7263916 7264214 7264398 7265581

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.

Voluntary or Mandated:

Voluntary: Firm initiated