FDA Issues Class I Recall for Teleflex Catheter System: Potential for Serious Injury and Blockage
Introduction: The US Food and Drug Administration (FDA) has issued a Class I recall for more than 260,000 catheter systems manufactured by Teleflex, specifically its subsidiary Arrow International. The recall was initiated due to concerns of catheter separation and leakage, which pose a risk of serious injury or even death. This article provides an overview of the recall, the potential consequences of the faulty device, and the impact it may have on the medical industry.
The FDA has designated the recall as Class I, indicating the highest level of severity, as the device has the potential to cause serious harm or fatality. The recall specifically targets Teleflex’s Arrow Endurance Dwell Peripheral Catheter System, which has been associated with reports of catheter separation and leakage.
If the catheter breaks while inserted in a blood vessel, fragments from the device can travel to other parts of the body, leading to heart attacks or pulmonary embolisms. Additionally, the faulty device can cause blockage of blood vessels, inadequate blood flow, injury to blood vessel walls, and the formation of blood clots.
Teleflex/Arrow International has received 83 complaints related to the faulty catheter system, with 18 reported patient injuries. However, no deaths have been reported thus far.
As part of the Class I recall, distributors of the device are required to retrieve the products and return them to Teleflex. Medical facilities utilizing the catheter system should cease its use and quarantine any remaining items.
The Arrow Endurance Extended Dwell Peripheral Catheter System by Teleflex accounted for nearly 75% of hospital-based peripherally inserted catheter lines (PICC) sales in the USA in 2022, and nearly 60% in 2021. This recall thus affects a significant portion of PICC sales in the country, potentially leading to procedure delays and hospitals seeking alternative PICC manufacturers such as CR Bard.
Teleflex has faced previous product issues, and this recall adds to its history of concerns. Earlier this year, the company recalled batches of Rüsch endotracheal tube devices and has also issued recalls for respiratory filters and Arrow lumen access kits.
Filing a Product Liability Lawsuit and the Importance of an Experienced Lawyer
In cases like the Teleflex catheter system recall, victims who have suffered harm or injuries may consider filing a product liability lawsuit. These lawsuits hold manufacturers accountable for the damages caused by their defective products. It is crucial for victims to seek the assistance of an experienced product liability attorney to navigate the legal process and ensure they receive fair compensation for their losses.
Why Choose Parker Waichman LLP
When faced with a product liability case, selecting a reputable and experienced attorney is of utmost importance. Parker Waichman LLP stands out as a leading law firm with a proven track record in handling product liability lawsuits. Their team of dedicated attorneys possesses extensive knowledge and expertise in this field, ensuring they can effectively pursue claims on behalf of their clients. With their commitment to providing personalized attention and achieving favorable outcomes, Parker Waichman LLP is the best choice for victims seeking justice in this type of civil lawsuit.
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