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

HRS study finds Frequent Coffee Consumption Lowers Chance of Arrhythmias. #HRS #HRS20 Heartrhythm20
News | EP Lab | May 28, 2020
May 28, 2020 – A recent study revealed that drinking a couple of cups of coffee per day does not lead to a greater ri
he Actus AcQMap EP 3-D mapping catheter used  to speed  electromapping and procedure times.

he Actus AcQMap EP 3-D mapping catheter used  to speed  electromapping and procedure times.

News | EP Lab | May 20, 2020
May 20, 2020 — Acutus Medical and Biotronik announced a new alliance to provide a comprehensive portfolio of...
Thermedical, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and Durablate catheter.
News | EP Lab | May 19, 2020
May 19, 2020 – Thermedical, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), an
HRS presentations included BlueSync Evaluation study for Medtronic MyCareLink Heart mobile app and Micra TPS CED Study
News | EP Lab | May 14, 2020
May 14, 2020 – Medtronic announced results from late-breaking clinical trials evaluating the MyCareLink Heart mobile
Etripamil Nasal Spray Does Not Meet Primary Endpoint in Treating Supraventricular Tachycardia in the NODE-301 trial presented at Heart Rhythm 2020. #heartrhythm2020 #HRS2020
News | EP Lab | May 13, 2020
May 13, 2020 — The patient-administered nasal spray drug etripamil did not meet its primary endpoint in treating pati
Medtronic Cobalt and Crome ICD
News | EP Lab | May 12, 2020
May 12, 2020 — Medtronic has received FDA approval for its Cobalt and Crome implantable cardioverter-defibrillators (
The CardioFocus HeartLight Excalibur Balloon X3 ablation system allows direct visualization of the laser ablation procedure, helping reduce use of X-ray angiography and reducing procedure time. FDA clears, approved, the HeartLight X3 Laser Ablation System to Treat Atrial Fibrillation.

The CardioFocus HeartLight Excalibur Balloon X3 ablation system allows direct visualization of the laser ablation procedure, helping reduce use of X-ray angiography and reducing procedure time.

News | EP Lab | May 12, 2020
May 12, 2020 — The U.S. Food and Drug Administration (FDA) has cleared the next-generation CardioFocus Inc.
EP lab photo from Philips Healthcare
News | EP Lab | April 30, 2020
May 1, 2020 — The Heart Rhythm Society (HRS) has created a COVID-19 Task Force to make recommendations related to edu
The European Heart Rhythm Association (EHRA) electrophysiology (EP) annual meeting cancelled due to coronavirus. #COVID19 #coronavirus #2019nCoV
Feature | EP Lab | March 10, 2020 | Dave Fornell, Editor
March 10, 2020 — Novel coronavirus (...
The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical SuperMap, an addition to its AcQMap 3-D imaging and mapping system used to guide electrophysiology (EP) catheter ablation procedures. Adding the SuperMap mode to the AcQMap system enables users to visualize any atrial rhythm in less than three minutes. Rapidly mapping and re-mapping the whole heart chamber facilitates a new procedural workflow in EP ablation, making it practical to execute an iterative "map, ablate, re-map" approach.
News | EP Lab | March 05, 2020
March 5, 2020 — The U.S.