--- title: "HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: CLass I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange" description: "HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: CLass I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange" --- - Search Search Close this search box. - Download Forms - [Make a Payment](https://secure.lawpay.com/pages/ironsandirons/trust) - [(252) 215-3000](tel:252-215-3000) [![Irons and Irons](https://blog.theironslawfirm.com/hs-fs/hubfs/irons-law-logo.png?width=178&height=46&name=irons-law-logo.png)](https://theironslawfirm.com/) - [Personal Injury](https://theironslawfirm.com/injury-law) - [Auto Accident](https://theironslawfirm.com/injury-law/personal-injury/car-accident) - [Motorcycle Accident](https://theironslawfirm.com/injury-law/personal-injury/motorcycle-accident) - [Nursing Home Abuse](https://theironslawfirm.com/injury-law/personal-injury/nursing-home-abuse) - [Rideshare Accidents](https://theironslawfirm.com/injury-law/personal-injury/rideshare-accidents) - [Slip and Fall](https://theironslawfirm.com/injury-law/personal-injury/slip-and-fall) - [Traumatic Brain Injury](https://theironslawfirm.com/injury-law/personal-injury/brain-injury) - [Truck Accident](https://theironslawfirm.com/injury-law/personal-injury/trucking-accident) - [Wrongful Death](https://theironslawfirm.com/injury-law/personal-injury/wrongful-death) - [Divorce](https://theironslawfirm.com/divorce) - [Separation Agreements](https://theironslawfirm.com/divorce/separation-agreements) - [Divorce Options](https://theironslawfirm.com/divorce/options) - [Absolute Divorce](https://theironslawfirm.com/divorce/absolute) - [Collaborative Divorce](https://theironslawfirm.com/divorce/collaborative) - [High Net Worth Divorce](https://theironslawfirm.com/divorce/high-net-worth) - [Military Divorce](https://theironslawfirm.com/divorce/military-divorce) - [Division of Pensions, 401(k) & Retirement Accounts](https://theironslawfirm.com/divorce/division-of-pension-and-retirement-accounts) - [Post Separation Support and Alimony](https://theironslawfirm.com/divorce/support-and-alimony) - [Property Distribution](https://theironslawfirm.com/divorce/property-distribution) - [5 Critical Questions For Your Initial Consultation](https://theironslawfirm.com/5-consultation-questions) - [Family Law](https://theironslawfirm.com/family-law) - [Child Custody](https://theironslawfirm.com/family-law/child-custody) - [Child Custody Modification](https://theironslawfirm.com/family-law/child-custody-modification) - [Child Support / Modification](https://theironslawfirm.com/family-law/child-support-modification) - [Collaborative Family Law](https://theironslawfirm.com/family-law/collaborative-family-law) - [5 Critical Questions For Your Initial Consultation](https://theironslawfirm.com/5-consultation-questions) - [Education Law](https://theironslawfirm.com/education-law) - [East Carolina University/Pitt Community College Disputes](https://theironslawfirm.com/education-law/ecu-college-disputes) - [Public And Private School Disputes](https://theironslawfirm.com/education-law/school-disputes) - [Malpractice](https://theironslawfirm.com/injury-law/medical-malpractice) - [Medical Malpractice](https://theironslawfirm.com/injury-law/medical-malpractice) - [Dental Malpractice](https://theironslawfirm.com/injury-law/personal-injury/dental-malpractice) - [Pharmaceutical Malpractice](https://theironslawfirm.com/injury-law/pharmaceutical-malpractice) - Attorneys - [Gib Irons](https://theironslawfirm.com/about/gib-irons) - [Ben G. 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Blog](https://blog.theironslawfirm.com) [Subscribe](https://blog.theironslawfirm.com/heartmate-ii-lvas-pocket-system-controller-by-abbott-thoratec-class-i-recall-due-to-risk-of-patient-injury-andor-death-during-backup-controller-exchange#popup-form) ### Subscribe via Email [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) # HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: CLass I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange May 24, 2017 Written by: Harry Albritton - Share - Share - Share - [Copy](https://blog.theironslawfirm.com/heartmate-ii-lvas-pocket-system-controller-by-abbott-thoratec-class-i-recall-due-to-risk-of-patient-injury-andor-death-during-backup-controller-exchange) Copied the Url Abbott-Thoratec has received a total of 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital. Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death. BACKGROUND: The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. The controller is powered by batteries or connected to a main power supply. The HeartMate II LVAS Pocket System Controller is intended for use inside or outside of the hospital. A back-up system controller is provided to each patient for use in case of a device alarm or malfunction. Instructions and training are provided on how to switch from one system controller to the other. Model/Item Numbers recalled are: 105109, 106015, 106762, 107801 and Manufactured July 2012 to December 2016. The recall was initiated March 30, 2017. RECOMMENDATION: On March 29, 2017, Abbott-Thoratec sent an "Urgent Medical Device Correction" letter to affected customers. The letter identified the following actions to be taken: \*  New HeartMate II LVAS Pocket System Controller patients will receive upgraded hardware and software (to include a fully upgraded system controller with new yellow alignment markings and new lead/driveline) from their ventricular assist device (VAD) coordinator. \*    Existing HeartMate II LVAS Pocket System Controller patients will receive updated device software and alarm guides for both their primary and back-up controllers. If existing patients need their controller replaced (if damaged or an old model controller), Abbott-Thoratec will replace the controller at no cost, but thepatient's implanted drive line will not be changed to have matching yellow markings. \*  Abbott-Thoratec will contact all affected health care providers to coordinate office visits, and receipt of software updates and updated labeling.   Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:   \*    Complete and submit the report Online: [www.fda.gov/MedWatch/report](https://www.fda.gov/MedWatch/report)   \*    Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.   Please see the complete MedWatch Safety Alert at: [https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560222.htm](https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560222.htm) <[http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwNTIzLjczNzM4MzQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDUyMy43MzczODM0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDE3NjY4JmVtYWlsaWQ9Y2FzZXlAbmNkYnMuY29tJnVzZXJpZD1jYXNleUBuY2Ricy5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560222.htm?source=govdelivery&utm\_medium=email&utm\_source=govdelivery](http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwNTIzLjczNzM4MzQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDUyMy43MzczODM0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDE3NjY4JmVtYWlsaWQ9Y2FzZXlAbmNkYnMuY29tJnVzZXJpZD1jYXNleUBuY2Ricy5jb20mZmw9JmV4dHJhPU11bHRpdmFyaWF0ZUlkPSYmJg==&&&100&&&https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560222.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery) ### [Harry Albritton](https://blog.theironslawfirm.com/author/harry-albritton) Harry H. Albritton, Jr. is a passionate attorney representing victims of negligence and malpractice, with deep roots in eastern North Carolina. A graduate of East Carolina University, he returned to practice law in Pitt County after obtaining his law degree from Ohio Northern University. Throughout his career, he has successfully handled a diverse range of cases, from minor car accidents to multi-million dollar catastrophic injuries, and has been recognized for his legal abilities by Super Lawyers and The National Trial Lawyers. When not practicing law, he prioritizes spending time with his wife and three sons, engaging in outdoor activities such as hiking, biking, and kayaking. ### Related Posts 2 min read #### [North Carolina Contributory Negligence Laws](https://blog.theironslawfirm.com/north-carolina-contributory-negligence-laws) [Read more](https://blog.theironslawfirm.com/north-carolina-contributory-negligence-laws) [Pharmaceutical Malpractice](https://blog.theironslawfirm.com/tag/pharmaceutical-malpractice-articles) 1 min read #### [Injectable Products by SCA Pharmaceuticals: Recall - Potential Contamination](https://blog.theironslawfirm.com/injectable-products-by-sca-pharmaceuticals-recall-potential-contamination) [Read more](https://blog.theironslawfirm.com/injectable-products-by-sca-pharmaceuticals-recall-potential-contamination) [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) 2 min read #### [Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath](https://blog.theironslawfirm.com/abbott-vascular-recalls-coronary-catheters-due-to-risks-stemming-from-difficulty-removing-balloon-sheath) [Read more](https://blog.theironslawfirm.com/abbott-vascular-recalls-coronary-catheters-due-to-risks-stemming-from-difficulty-removing-balloon-sheath) [![IRONS & IRONS P.A.](https://blog.theironslawfirm.com/hs-fs/hubfs/Irons%20and%20Irons/Pillar-Graphic.png?width=134&height=67&name=Pillar-Graphic.png)](https://theironslawfirm.com/) Irons & Irons P.A. 620 Lynndale Ct Suite A Greenville, NC 27858 Monday-Friday 9am-5pm Phone: [252-215-3000](tel:252-215-3000) PRACTICE AREAS - [Personal Injury](https://theironslawfirm.com/injury-law) - [Medical Malpractice](https://theironslawfirm.com/injury-law/medical-malpractice) - [Divorce](https://theironslawfirm.com/divorce) - [Family Law](https://theironslawfirm.com/family-law) - [Education Law](https://theironslawfirm.com/education-law) ATTORNEYS - [Gib Irons](https://theironslawfirm.com/about/gib-irons) - [Ben G. 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