Teleflex and Arrow International have recalled the ARROW Endurance Extended Dwell Peripheral Catheter System for risk of catheter separation and leakage.
The recall, which impacts 262,016 devices distributed in the U.S. from Oct. 26, 2018 through May 10, 2023, has been classified by the FDA as Class I.
The ARROW Endurance Extended Dwell Peripheral Catheter System allows health care providers access to a patient’s peripheral vascular system, for short term use, to sample blood, monitor blood pressure, or administer fluids, blood, and blood products.
Teleflex, and their subsidiary Arrow International, are recalling the ARROW Endurance Extended Dwell Peripheral Catheter System after 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.
This issue may cause serious injury, including 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.
Teleflex/Arrow International reports 83 complaints related to this issue. There have been 18 reported injuries and no deaths.
