Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters

Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters

Article
Health Safety and Recalls
Nutrition & Dietetics
Contributed byLester Fahrner, MDFeb 29, 2020

Company Announcement Date: February 20, 2020

FDA Publish Date: February 20, 2020

Product Type: Medical Devices

Reason for Announcement: Catheter balloon may not deflate as intended

Company Name: Abbott

Brand Name: Abbott

Product Description: Coronary dilatation catheters

Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. This recall does not affect patients who have successfully undergone cardiac procedures using these devices.

Abbott issued a Field Safety Notice (FSN)

External Link Disclaimer

on Jan. 29, 2020, to physicians and hospitals who received coronary catheters from the affected lots and is arranging the return and replacement of all remaining products. The affected products were manufactured between July 29, 2019 – Dec. 19, 2019 and distributed between Aug. 16, 2019 – Jan. 3, 2020. The total number of distributed units from identified lots potentially affected is 40,429.

Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart. The balloons from the impacted lots may not deflate as intended. Potential risks include prolonged cardiac ischemia, air embolism, thrombosis, myocardial infarction and additional intervention, such as surgery that could lead to post-operative complications which include death.

The FDA has classified this as a Class I recall. The frequency of reported events that include slow, partial and failure to deflate the balloon, is 0.12 percent worldwide. At the time the FSN was issued, there were no reports of patient death. Since the issuance of the FSN, Abbott has become aware of one reported case in which the inability to deflate the balloon necessitated intervention, which resulted in post-procedural complications leading to a patient death.

Healthcare providers that received the Jan. 29, 2020 FSN

External Link Disclaimer

are directed to read the document and follow its instructions.

Adverse reactions or quality problems experienced with the use of this product can be reported to Abbott at (800) 227-9902. Reports may also be sent to the FDA's MedWatch Adverse Event Reporting program by completing Form FDA 3500 online at FDA.gov, https://www.fda.gov/safety/medwatch/, calling 1-800-FDA-1088 of faxing to 1 800 FDA 0178.

—more—

 

 

For U.S. Important Safety Information about NC Trek RX, visit https://www.cardiovascular.abbott/us/en/hcp/products/percutaneous-coronary-

External Link Disclaimer

intervention/nc-trek-coronary-dilation-catheters.html#prodisi

External Link Disclaimer

 

 

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Was this article helpful

On the Article

Lester Fahrner, MD picture
Approved by

Lester Fahrner, MD

Chief Medical Officer, DoveMed Team

0 Comments

Please log in to post a comment.

Related Articles

Test Your Knowledge

Asked by users

Related Centers

Loading

Related Specialties

Loading card

Related Physicians

Related Procedures

Related Resources

Join DoveHubs

and connect with fellow professionals

Related Directories

Who we are

At DoveMed, our utmost priority is your well-being. We are an online medical resource dedicated to providing you with accurate and up-to-date information on a wide range of medical topics. But we're more than just an information hub - we genuinely care about your health journey. That's why we offer a variety of products tailored for both healthcare consumers and professionals, because we believe in empowering everyone involved in the care process.
Our mission is to create a user-friendly healthcare technology portal that helps you make better decisions about your overall health and well-being. We understand that navigating the complexities of healthcare can be overwhelming, so we strive to be a reliable and compassionate companion on your path to wellness.
As an impartial and trusted online resource, we connect healthcare seekers, physicians, and hospitals in a marketplace that promotes a higher quality, easy-to-use healthcare experience. You can trust that our content is unbiased and impartial, as it is trusted by physicians, researchers, and university professors around the globe. Importantly, we are not influenced or owned by any pharmaceutical, medical, or media companies. At DoveMed, we are a group of passionate individuals who deeply care about improving health and wellness for people everywhere. Your well-being is at the heart of everything we do.

© 2023 DoveMed. All rights reserved. It is not the intention of DoveMed to provide specific medical advice. DoveMed urges its users to consult a qualified healthcare professional for diagnosis and answers to their personal medical questions. Always call 911 (or your local emergency number) if you have a medical emergency!