News | Leads Implantable Devices | August 05, 2019

Abbott Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires

Exposed aluminum wires identified in Class I recall may prevent defibrillation therapy

Abbott Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires

August 5, 2019 — Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process, causing some aluminum wires to be partially exposed. ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor.  The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure.

Abbott ICDs provide pacing for slow heart rhythms and electrical shock or pacing to stop dangerously fast heart rhythms. These cardiac devices are implanted under the skin in the upper chest area with connecting insulated wires called leads that go into the heart. A patient may need an ICD if their heartbeat is too slow (bradycardia), too fast (tachycardia) or needs coordination to treat heart failure.

On June 21, 2019, Abbott hand-delivered an Urgent Medical Device Recall letter to customers. The letter directed customers to take the following actions:

  • Review the device model and serial numbers to identify the impacted patients and return the acknowledgement form to the sales representative.

Device explant and replacement are recommended. Abbott will work with customers to provide an Abbott replacement device. The recall affects all lots manufactured between April 5 and May 29 of this year; this includes model numbers CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C and CD2411-36Q. 

Abbott is not aware of any related reports of this failure occurring in any affected implanted devices. Of the 108 devices recalled in the U.S., 31 have been implanted. The complaints and MDRs available have either reported that the affected devices have been replaced or are scheduled to be replaced with another ICD generator. None of the complaint or MDRs indicate that any patient harm or adverse events have occurred, and no deaths have been reported.

Healthcare professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by fax to 1-800-FDA-0178. Healthcare professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

For more information: www.cardiovascular.abbott/us/en/hcp/resources/product/advisories.html

 

Related ICD Content

New Technology and Market Challenges Facing Implantable Cardioverter Defibrillators

Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD

Use of the Interventional CRT Approach to Solve Issues With LV Lead Placement

New Approaches to EP Lead Management

VIDEO: EP Lead Extraction Strategies

Related Content

The Stereotaxis Genesis EP robotic navigation system.

The new generation Stereotaxis Genesis EP robotic navigation system.

News | EP Lab | September 01, 2021
September 1, 2021 — Stereotaxis and Shanghai Microport EP Medtech Co., Ltd.
Ventricular Tachycardia Recurrence, Hospitalization and Death Reduced With Catheter Ablation as First Line Therapy. Results from an international clinical trial show a significant reduction in risk of ventricular tachycardia (VT) recurrence, cardiovascular hospitalization, and sudden cardiac death (SCD) death when catheter ablation is used as an early first-line treatment for patients with structural heart disease. Led by study coordinating center, the University of Chicago, The PAUSE-SCD trial. #HRS21
News | EP Lab | August 09, 2021
August 9, 2021 – Results from an international clinical trial show a significant reduction in risk of ventricular tac
Heart Rhythm Society, HRS, 2021 Late-Breaking Clinical Trials in Electrophysiology. #HRS #HRS2021 #HRS21 #Heartrhythm21
Feature | EP Lab | August 09, 2021
July 28, 2021 — Here is the complete list of late-breaking clinical trials (LBCT) and links to articles on all of the
An example from the study of the Biosense Webster NuVision 3D/4D ICE imaging capability showing the left atrial appendage (LAA) visualization on 3D ICE. The system allows the user to place a false lighting source to be placed in different positions to change the lighting and shadows to better visualize the anatomy.

An example from the study of the Biosense Webster NuVision 3D/4D ICE imaging capability showing the left atrial appendage (LAA) visualization on 3D ICE. The system allows the user to place a false lighting source to be placed in different positions to change the lighting and shadows to better visualize the anatomy. 

News | EP Lab | August 05, 2021 | By Dave Fornell, Editor
August 5, 2021 —  A prospective, non-randomized, multicenter, first-in-human clinical study found good diagnostic and
EP lab ablation catheter. #HRS21 #HRS2021
News | EP Lab | August 03, 2021
August 3, 2021 — A subgroup analysis of the EAST – AFNET 4 study population revealed early initiation of rhythm contr
emporary Spinal cord stimulation (SCS) was effective in suppressing post-operative atrial fibrillation (AF) after coronary artery bypass (CAGB) surgery CABG without any adverse events in a randomized pilot study. The TEmporary Spinal CoRd StiMulatIon to PrevenNt Atrial FibrillaTION AFter Cardiac Surgery (TerminationAF) study was presented as a late-breaking study presented at the 2021 Heart Rhythm meeting, the annual conference of the Heart Rhythm Society (HRS).  #HRS21 #HRS2021
News | EP Lab | August 03, 2021
August 4, 2021 — Temporary Spinal cord stimulation (SCS) was effective in suppressing post-operative...
Oral Contraceptives Cause Increased Risk of Cardiac Events in Woman With Long QT Syndrome. #HRS21 #HRS2021 #womenshealth
News | EP Lab | August 03, 2021
August 3, 2021 – Results from a new clinical trial show an increased risk of cardiac events, like sudden cardiac deat
A recent study unveiled a novel sinus node ablation technique that provides a safe and effective treatment option for patients suffering from symptomatic, drug-resistant inappropriate sinus tachycardia (IST). Results of the Susruta-IST Registry were presented as a late-breaking clinical trial at Heart Rhythm 2021, the annual meeting of the Heart Rhythm Society (HRS). #HRS21 #HRS2021

A novel sinus node ablation technique provides a safe and effective treatment option for patients suffering from symptomatic, drug-resistant inappropriate sinus tachycardia (IST). Results of the Susruta-IST Registry were presented as a late-breaking clinical trial at Heart Rhythm 2021.

News | EP Lab | August 03, 2021
August 3, 2021 – A recent study unveiled a novel sinus node...
The Philips EPD Kodex system for the EP lab.
News | EP Lab | August 03, 2021
August 3, 2021 – A new analysis of the Catheter Ablation vs.
The new Octaray high-density mapping catheter from Biosense Webster has 48 electrodes to enable faster and more detailed electromapping of the heart to better guide ablation procedures.

The new Octaray high-density mapping catheter from Biosense Webster has 48 electrodes to enable faster and more detailed electromapping of the heart to better guide ablation procedures. Photo by Dave Fornell

News | EP Lab | August 03, 2021
August 3, 2021 – Biosense Webster, the global leader in cardiac arrhythmia treatment and part of Johnson & Johnso