CLASS II Device recall · Reported 18 May 2016 · FDA Enforcement Report

Ellipse ICD (Implantable Cardioverter Defibrillator) recalled

St Jude Medical is recalling Ellipse ICD (Implantable Cardioverter Defibrillator), distributed nationwide in the US. The recall was initiated on 31 Mar 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. 7263877 7263892 7263900 7263904 7264199 7265399 7265400 7265401 7263916 7264214 7264398 7265581

Quantity recalled127 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1632-2016
FDA event ID: 73837
Recalling firm: St Jude Medical, Sylmar, CA
Classification: Class II
Status: Terminated
Recall initiated: 31 Mar 2016
FDA classified: 9 May 2016
Reported: 18 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

31 Mar 2016	Recall initiated by company
9 May 2016	Classified by FDA	+39 days
18 May 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Connecticut Florida Georgia New Jersey South Carolina

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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