The FDA today designated Teleflex’s recall of its Arrow Endurance extended dwell peripheral catheter system as Class I, the most serious type of medical device recall.
The recall involved 262,016 devices distributed from October 26, 2018, to May 10, 2023, according to the FDA.
Teleflex and its Arrow International subsidiary have reported 83 complaints related to this issue. There are reports of 18 injuries but no deaths.
The Endurance system provides short-term access to a person’s peripheral vascular system, enabling health providers to sample blood, monitor blood pressure, or administer fluids, blood, and blood products.
Teleflex initiated a recall on May 19 after receiving reports of catheter separation or leakage. If the catheter separates while in a blood vessel, the catheter fragments could be left in the bloodstream and may migrate to other places in the body. The situation could cause a person to experience a blockage of blood vessels, inadequate blood flow, injury to blood vessel walls, blood clots, blockage of the lung arteries (pulmonary embolism), heart attack, or death, according to the FDA.
The company’s letter to customers instructs them to check their inventory for products within the recall’s scope — and stop using and quarantine the affected products.