Dive Brief:
- Teleflex’s recall of its Arrow Endurance Extended Dwell Peripheral Catheter System was categorized by the U.S. Food and Drug Administration as a Class I event, the most severe type of recall.
- The company began the recall in May after receiving 83 complaints, including 18 reports of injuries. If the catheter separates while in a blood vessel, fragments could spread to other parts of the body and cause adverse events including heart attack and death, the FDA said in a notice.
- Hospitals should check if they have any of the 262,016 devices recalled in the U.S. and stop using the affected products. Teleflex is asking clinical staff overseeing patients who are currently using an affected product to weigh the risks and benefits of removing and replacing the device.
Dive Insight:
Teleflex acquired Arrow International in 2007 to gain control of a portfolio of vascular access devices. That portfolio now includes Arrow Endurance Extended Dwell Peripheral Catheter System, a product that enables a patient to receive continuous intravenous therapy for the length of a hospital stay. Using the system, healthcare professionals can sample blood, monitor blood pressure or administer fluids.
Between May 2018 and May 2023, Teleflex received 83 complaints about separations and leakage. The reports included 18 injuries. None of the patients covered by the complaints suffered long-term injuries or died as a result of separations or leakage.
Teleflex sent an urgent medical device recall notice to its customers in May. The company said it had received reports of separation and explained the cardiovascular complications that could happen if the fault occurred when the device was in a vein or artery. The FDA reiterated those risks in the notice it published this week to categorize the recall as a high-risk Class I event.
The company’s vascular access division, which sells the catheter and other devices, accounted for 25% of Teleflex’s sales in the first quarter. Sales grew 6.9% to help Teleflex achieve 10.8% growth overall. The growth followed a period in which vascular access sales fell compared to quarters that benefited from business related to the COVID-19 pandemic.
Teleflex disclosed another recall earlier this month. The company initiated a global recall of tubes used in oral or nasal intubation after receiving reports that a part of the device may disconnect and lead to oxygen desaturation.