On June 26, 2023, the U.S. Food and Drug Administration (FDA) identified a product recall by Teleflex and its subsidiary Arrow International for their product the ARROW Endurance Extended Dwell Peripheral Catheter System. The recall was first initiated by the firm on May 19, 2023, because of the risk of catheter separation and leakage.
The FDA has identified this case as a Class I recall, the most serious kind, which can imply that the use of these devices may cause serious injuries or death. The recall affects a considerable sum of 262,016 devices that were distributed in the U.S. from October 26, 2018, to May 10, 2023. The firm has reported a total of 83 complaints related to the issue, with 18 reported injuries and no deaths at this time.
The device is used to give health practitioners access to a patient’s peripheral vascular system. Where they can then facilitate the collection of sample blood and blood pressure monitoring, as well as the administration of fluids, blood, and blood products.
Teflex and Arrow International initiated the recall of the ARROW Endurance Extended Dwell Peripheral Catheter System due to reports of separation or leakage with the catheters. If these catheters separate while in venous or arterial use, the fragments could end up in the patient’s bloodstream and migrate to other regions of the body. This can lead to serious injuries, such as blood vessel blockages, blood flow issues, injuries to the blood vessel walls, blood clots, lung artery blockages (also known as pulmonary embolism), heart attacks, or even death.
The individuals most at risk are those who have received care with the ARROW Endurance Extended Dwell Peripheral Catheter System.
To learn more about the recall of the ARROW Endurance Extended Dwell Peripheral Catheter System, click here.
HOW CAN MEYERS & FLOWERS HELP
The Meyers & Flowers team is dedicated to protecting the rights of those injured by defective and dangerous medical devices. If you or a family member have been injured by ARROW Endurance Extended Dwell Peripheral Catheter System, we encourage you to contact us to explore your legal options. Contact us at 630-576-9696 for your free, no obligation case evaluation or find more information here.