Please ensure Javascript is enabled for purposes of website accessibility

Abbott Labs Recalls Some Catheters Due to Possible Defects

By Mark Prvulovic – Feb 20, 2020 at 9:01AM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The company issued a Class I recall of recently manufactured lots of two models because of potential balloon deflation problems.

The U.S. Food and Drug Administration stated on Wednesday that some lots of two catheters models sold by Abbott Laboratories (ABT -1.56%) needed to be recalled due to potentially severe safety issues. The agency defined them as Class I recalls, the most serious type, and it warned that using these devices could cause serious injury or even death.

The models in question are the NC Trek RX and the NC Traveler RX coronary dilation catheters with balloon diameters of 4.0mm, 4.5mm, and 5.0mm. The issue is that the balloons may not deflate the way they are supposed to. The problem seems to have been caused by overexposure to heat during the manufacturing process, which weakens the material near the balloon.

A medical professional holding a catheter.

Image source: Getty Images.

"Use of these devices may cause serious adverse health consequences, such as prolonged cardiac ischemia (reduced blow flow to the heart), air embolism, thrombosis (clot in the artery), myocardial infarction (heart attack), and additional surgery that could lead to post-operative complications, including death," warned the agency in an official statement.

Additional details

The recall applies to 13,891 devices that were distributed between August 2019 and January 2020. So far, there have been 13 complaints recorded relating to the problem, with one confirmed death.

This isn't the first time there's been an issue with Abbott's catheters. Back in 2017, the healthcare giant warned hospitals and healthcare professionals to stop using a number of its catheters due to problems with the balloon sheath. As many as 449,661 catheters were identified as potentially being defective at the time.

Mark Prvulovic has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Abbott Laboratories Stock Quote
Abbott Laboratories
ABT
$96.76 (-1.56%) $-1.53

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
326%
 
S&P 500 Returns
102%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 10/02/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.