Medical Device recall: USFDA classifies recall of Catheter Kits as ‘most serious’

The Medical Device recall stems from a concerning manufacturing error identified by Teleflex.

June 14, 2024

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Last Updated on December 22, 2024 by The Health Master

Medical Device recall

This article covers a recent Medical Device recall of intra-aortic balloon catheter kits by Teleflex, classified by the U.S. Food and Drug Administration (USFDA) as a “most serious” Class I Medical Device recall.

These catheters are critical medical devices used to improve blood flow to the heart muscle in various scenarios, including cardiac surgery, non-cardiac surgery, heart failure treatment, and acute coronary syndrome.

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Reason for Medical Device Recall

The Medical Device recall stems from a concerning manufacturing error identified by Teleflex.

The issue involves Arrow FiberOptix Intra-Aortic Balloon Catheter Kits and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits, totaling 16,959 units.

This defect has the potential to cause the inflatable balloon within the catheter to become overtwisted.

Potential Risks

The USFDA emphasizes the potential dangers of using an affected catheter.

An overinflated balloon could lead to severe complications, including:

Blood loss
Artery tears
Unstable blood pressure
Impeded blood flow to the heart (ischemia)
Death

Teleflex, in collaboration with the USFDA, has reported 322 complaints potentially linked to this issue.

Even more concerning are the 31 injuries and 3 deaths potentially associated with the faulty catheters.

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What Should Healthcare Providers Do?

Healthcare providers are urged to take immediate action regarding this critical Medical Device recall.

Here are the key steps:

Identify Affected Inventory: Check your stock of Arrow FiberOptix and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits. Look for specific lot numbers or product codes provided in the official Medical Device recall notice from Teleflex or the USFDA.
Halt Use of Recalled Devices: Do not use any identified catheters from the recalled lots.
Return Recalled Products: Follow Teleflex’s instructions for returning the affected devices.
Report Adverse Events: If you have experienced any issues with these catheters, report them to the USFDA’s MedWatch program.

Staying Informed and Patient Safety

For the latest updates and detailed information about the specific devices involved in the Medical Device recall, healthcare providers can refer to the official announcements from Teleflex and the USFDA.

Prioritizing Patient Safety

This Medical Device recall highlights the importance of vigilant monitoring and regulatory oversight in the medical device industry.

By taking swift action and adhering to the Medical Device recall instructions, healthcare professionals can help ensure patient safety and minimize potential harm.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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