Teleflex, Arrow International Recall Arrow Endurance Catheter System

Teleflex, and its subsidiary Arrow International, are recalling the Arrow Endurance Extended Dwell Peripheral Catheter System, according to a recent FDA statement, after initially sending customers an “Urgent Medical Device Recall” letter in mid-May.

The catheter system is used to access a patient’s peripheral vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids, blood, or blood products. However, the companies are recalling the system, in what FDA is labeling a Class I recall, after reports of catheter separation or leakage.

If separation of the catheter occurs while in the blood vessel, fragments of the device could be left behind in the bloodstream and migrate to other areas in the body. Fragments in the body may cause serious injury, according to Teleflex, including blocking the blood vessels, inhibiting adequate blood flow, creating injury to the vessel walls, blood clots, blocking lung arteries, heart attack, or death.

Currently, the companies have received 83 complaints related to the issues, 18 of which reported injury, and there’s been no reported deaths. Affected product was distributed from Oct. 26, 2018, to May 10, 2023, and devices recalled in the United States have reached over 262,000.

Teleflex/Arrow International are recommending medical facilities and distributors check their inventory, find and quarantine affected product, and return all affected product to Teleflex.