--- title: "Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error" description: Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. This defect causes an out of specification gas mixture inside the device and may prevent the device from d --- - 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/defibrillation-crt-ds-and-implantable-cardiovert-defibrillators-icds-by-medtronic-class-i-recall-manufacturing-error#popup-form) ### Subscribe via Email [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) # Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error March 02, 2018 Written by: Harry Albritton - Share - Share - Share - [Copy](https://blog.theironslawfirm.com/defibrillation-crt-ds-and-implantable-cardiovert-defibrillators-icds-by-medtronic-class-i-recall-manufacturing-error) Copied the Url # Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error Preventing Electrical Shock Delivery **ISSUE**: Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process.  This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death. - Product Codes: NIK, LWS - Serial Numbers: See Complete List in Recall Notice - Manufacturing Dates: July 13, 2013 to August 8, 2017 - Devices Recalled in the U.S.: 48 units nationwide **BACKGROUND**: Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. **RECOMMENDATION**: On January 22 2018 Medtronic sent an Urgent Medical Device Recall notice to affected customers. The notice asked customers to: - Consider Prophylactic device replacement for patients who have been implanted with one of the affected devices. - Contact their Medtronic sales representative for terms and conditions for device warranties. - Review the recall notice and ensure appropriate staff is aware of the notice. Medtronic will offer a supplemental device warranty for affected devices. 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 ### [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 [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) 1 min read #### [Novopen Echo Insulin Delivery Device by Novo Nordisk: Recall - May Crack or Break If Exposed To Certain Chemicals](https://blog.theironslawfirm.com/novopen-echo-insulin-delivery-device-by-novo-nordisk-recall-may-crack-or-break-if-exposed-to-certain-chemicals) [Read more](https://blog.theironslawfirm.com/novopen-echo-insulin-delivery-device-by-novo-nordisk-recall-may-crack-or-break-if-exposed-to-certain-chemicals) [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) 1 min read #### [Vyaire Medical, Inc. 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