Catheters have a pretty specific function, and that definitely does not include separating or leaking. According to a recent Cardiovascular Business article, the FDA issued a Class I recall for over 250,000 catheters manufactured by Arrow International, a subsidiary of Teleflex. As you’ve probably guessed, the recall is due to the risk of device separation and leakage, which can lead to serious injuries or death. The affected product is the Arrow Endurance Extended Dwell Peripheral Catheter System, commonly used for short-term access to a patient's peripheral vascular system during procedures like blood sample collection or fluid administration.
Catheter separation or leakage during use poses significant risks, as fragments left in the bloodstream can migrate and cause blockages, inadequate blood flow, blood clots, pulmonary embolism, heart attack, or even death. So far, there have been 83 complaints, including 18 reported injuries, but no deaths. Medical facilities and distributors are advised to quarantine and return the recalled catheters, a process Teleflex has promised to assist with.