--- title: Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath description: Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath --- - 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. Irons II](https://theironslawfirm.com/about/ben-g-irons-ii) - [Harry H. Albritton, Jr.](https://theironslawfirm.com/about/attorney-harry-h-albritton-jr) - [Brianne Lee Van Apeldoorn](https://theironslawfirm.com/about/brianne-lee-van-apeldoorn) - [Misty Waldroup](https://theironslawfirm.com/about/misty-waldroup) [Schedule Consultation](https://theironslawfirm.com/contact/consultation-request) [tel:252-215-3000](tel:252-215-3000) [Irons & Irons P.A. Blog](https://blog.theironslawfirm.com) [Subscribe](https://blog.theironslawfirm.com/abbott-vascular-recalls-coronary-catheters-due-to-risks-stemming-from-difficulty-removing-balloon-sheath#popup-form) ### Subscribe via Email [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) # Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath May 22, 2017 Written by: Harry Albritton - Share - Share - Share - [Copy](https://blog.theironslawfirm.com/abbott-vascular-recalls-coronary-catheters-due-to-risks-stemming-from-difficulty-removing-balloon-sheath) Copied the Url *The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.* ### Recalled Product(s): - Abbott NC Trek RX Coronary Dilatation Catheter, Abbott NC Traveler Coronary Dilatation Catheter, Abbott NC Tenku RX PTCA Balloon Catheter - Model/Item Numbers: See "[Full List of Affected Devices](https://www.fda.gov/medical-devices/medical-device-recalls/abbott-vascular-recalls-coronary-catheters-due-risks-stemming-difficulty-removing-balloon-sheath?source=govdelivery&utm_medium=email&utm_source=govdelivery)" - Lot Numbers: See "[Full List of Affected Devices](https://www.fda.gov/medical-devices/medical-device-recalls/abbott-vascular-recalls-coronary-catheters-due-risks-stemming-difficulty-removing-balloon-sheath?source=govdelivery&utm_medium=email&utm_source=govdelivery)" - Manufacturing Dates: January 1, 2015 to January 2, 2017 - Distribution Dates: January 1, 2015 to March 14, 2017 - Devices Recalled in the U.S.: 132,040 ### Device Use Abbott's Coronary Dilatation Catheters are indicated for use in the following cardiac procedures: - balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving blood flow to the heart; - balloon dilatation of a coronary artery occlusion (*blocked or clogged artery*), for the purpose of restoring coronary blood flow in patients with ST-segment elevation myocardial infarction (*heart attack*); and - balloon dilatation of a stent after implantation (2.00 mm - 5.00 mm balloon models only). *![Image of the Abbott Vascular NC Trek RX Coronary Dilatation Catheter](https://static.hsstatic.net/BlogImporterAssetsUI/ex/missing-image.png "Image of the Abbott Vascular NC Trek RX Coronary Dilatation Catheter") Image of the Abbott Vascular NC Trek RX Coronary Dilatation Catheter* ### Reason for Recall Abbott has initiated a voluntary recall of specific lots of three catheters due to 19 reports of injury, and 1 report of death associated with difficulty removing the protective balloon sheath, resulting in issues with inflating or deflating the balloon. Abbott is recalling products from the identified lots because physicians may experience difficulty in removing the protective balloon sheath. This can result in issues with inflating or deflating the balloon during procedures and may cause serious adverse health consequences including: air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and death. ### Who May be Affected - Hospitals and health care professionals using Abbott Vascular's NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and/or NC Tenku RX PTCA Balloon Catheter. - Patients undergoing cardiac procedures involving these catheters. ### What to Do On March 22, 2017, Abbott sent a "Field Safety Notice" letter to health care providers and risk managers informing them of the device's risks, and corrective actions that would be implemented to ensure ongoing product performance. The letter asked health care providers and risk managers to: - Reference the list of affected part numbers and lot numbers. - Immediately stop using the devices from the identified lots and remove or quarantine them. - Contact Abbott Vascular to obtain a Return Authorization Number. - Return all affected and unused products to Abbott Vascular. - Acknowledge receipt of the notification by returning the "Effectiveness Check Form" provided by Abbott Vascular by email to: [AVRegulatoryCompliance@av.abbott.com](mailto:AVRegulatoryCompliance@av.abbott.com), or via fax to: 1-951-914-5951 - Share the notification with other relevant personnel in their organization ### Contact Information Customers with questions may contact their local Abbott Vascular Representative, or contact Abbott's Customer Service Department at (800) 227-9902. ### Date Recall Initiated March 22, 2017 ### Full List of Affected Devices - [Abbott NC Trek RX Coronary Dilatation Catheter](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154375) - [Abbott NC Traveler Coronary Dilatation Catheter](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154376) - [Abbott NC Tenku RX PTCA Balloon Catheter](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=154377) ### Additional Resources - [Abbott Field Safety Notice (March 22, 2017)](https://www.vascular.abbott/content/dam/bss/divisionalsites/av/products/Coronary-Catheter-FSN-3-16-17.pdf) [![disclaimer icon](https://static.hsstatic.net/BlogImporterAssetsUI/ex/missing-image.png)](https://www.fda.gov/about-fda/website-policies/website-disclaimer) - [Press Release: Abbott Initiates Voluntarily Recall of Specific Lots of Three Coronary Catheters (May 12, 2017)](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/abbott-initiates-voluntarily-recall-specific-lots-three-coronary-catheters) - [Important Safety Information on NC Trek Catheters](https://www.vascular.abbott/content/dam/bss/divisionalsites/av/products/AP2936324_NC_Trek_RX_OTW_WIPCA.pdf) [![disclaimer icon](https://static.hsstatic.net/BlogImporterAssetsUI/ex/missing-image.png)](https://www.fda.gov/about-fda/website-policies/website-disclaimer) ### How do I report a problem? Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to [MedWatch: The FDA Safety Information and Adverse Event Reporting Program](https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda). Health care professionals employed by facilities that are subject to [FDA's user facility reporting requirements](https://www.fda.gov/medical-devices/postmarket-requirements-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities) should follow the reporting procedures established by their facilities. ### [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 [Pharmaceutical Malpractice](https://blog.theironslawfirm.com/tag/pharmaceutical-malpractice-articles) 2 min read #### [Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease](https://blog.theironslawfirm.com/clarithromycin-biaxin-drug-safety-communication-potential-increased-risk-of-heart-problems-or-death-in-patients-with-heart-disease) [Read more](https://blog.theironslawfirm.com/clarithromycin-biaxin-drug-safety-communication-potential-increased-risk-of-heart-problems-or-death-in-patients-with-heart-disease) [Medical Malpractice](https://blog.theironslawfirm.com/tag/medical-malpractice) 2 min read #### [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](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) [Read more](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) [Pharmaceutical Malpractice](https://blog.theironslawfirm.com/tag/pharmaceutical-malpractice-articles) 2 min read #### [Diphenoxylate Hydrochloride and Atropine Sulfate Tablets by Greenstone: Recall](https://blog.theironslawfirm.com/diphenoxylate-hydrochloride-and-atropine-sulfate-tablets-by-greenstone-recall) [Read more](https://blog.theironslawfirm.com/diphenoxylate-hydrochloride-and-atropine-sulfate-tablets-by-greenstone-recall) [![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. Irons II](https://theironslawfirm.com/about/ben-g-irons-ii) - [Harry Albritton](https://theironslawfirm.com/about/attorney-harry-h-albritton-jr) - [Brianne Lee Van Apeldoorn](https://theironslawfirm.com/about/brianne-lee-van-apeldoorn) RESOURCES - [Download Forms](https://theironslawfirm.com/download-forms) - [Blog](https://theironslawfirm.com/blog) ABOUT - [Reviews](https://theironslawfirm.com/about/client-reviews) - [Careers](https://theironslawfirm.com/about/careers) Copyright © 2024 Irons & Irons P.A.. All rights reserved. - [Disclaimer](https://theironslawfirm.com/disclaimer) - [Privacy Policy](https://theironslawfirm.com/privacy-policy) - - - - ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "Harry Albritton", "url" : "https://blog.theironslawfirm.com/author/harry-albritton" }, "dateModified" : "2024-03-08T15:25:14.539Z", "datePublished" : "2017-05-22T11:52:59.000Z", "headline" : "Abbott Vascular Recalls Coronary Catheters Due to Risks Stemming from Difficulty Removing Balloon Sheath", "mainEntityOfPage" : { "@id" : "https://blog.theironslawfirm.com/abbott-vascular-recalls-coronary-catheters-due-to-risks-stemming-from-difficulty-removing-balloon-sheath", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject" } } } ```