The US Food and Drug Administration (FDA) has recalled more than 260,000 catheter systems from Teleflex in a Class I recall after reports the device was prone to separation or leakage.
Made under Teleflex’s subsidiary Arrow International, the issues with Arrow Endurance Dwell Peripheral Catheter System have been identified as a potential cause for serious injury or death.
The FDA stated that if the catheter breaks whilst in a blood vessel, fragments from the device could travel to other parts of the body, causing a heart attack or a pulmonary embolism. Blockage of vessels, inadequate blood flow, blood vessel wall injury and blood clots are also listed as potential consequences from the faulty device.
So far, Teleflex/Arrow International has received 83 complaints, with 18 reported patient injuries. No deaths have been reported yet.
As per a Class I recall, any distributors of the device will have to pull the products and return them to Teleflex. For medical facilities using the catheter, use of the device should be stopped, and the items quarantined.
“Teleflex's Arrow Endurance Extended Dwell Peripheral Catheter System made up almost 75% of hospital-based peripherally inserted catheter lines (PICC) sales in the USA for 2022 and almost 60% in 2021. Therefore, this recall affects the majority of PICC sales in the USA. This may lead to procedure delays and hospitals turning to other leading PICC manufacturers like CR Bard,” GlobalData medical analyst Selena Yu told Medical Device Network.
“With Teleflex's Endurance PICC system being the leader in the market for the last few years, competitors may use this FDA recall to gain market share while Teleflex is focusing on troubleshooting this huge recall.”
The recall is the most recent in a history of product issues for the Pennsylvania, US-headquartered company. In June this year, Teleflex recalled batches of Rüsch endotracheal tube devices. The company has also issued recalls for respiratory filters and Arrow lumen access kits.
