Teleflex and its subsidiary Arrow International initiated a product recall of 262,016 Arrow Endurance Extended Dwell Peripheral Catheter systems on May 19, 2023. 83 complaints have been filed that the device can separate or leak when in a patient’s blood vessel. The FDA has classified this as a Class I recall, the most serious type of recall.
The problem: 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 causing serious injury including:
According to the release from Teleflex dated June 26, 2023, Teleflex/Arrow International reports 83 complaints related to this issue, 18 reported injuries and no deaths. As of today’s date, no litigation is pending; this is strictly an alert to the general public.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
Class I recalls are the most urgent because they have the potential to be the most harmful. The FDA defines these recalls as having a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
What is the device used for?
The device 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.
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