FDA announces recall of more than 300,000 catheter kits after 10 injuries, 1 death
The U.S. Food and Drug Administration (FDA) has announced that Arrow International, a subsidiary of Teleflex, is recalling more than 300,000 catheterization kits due to ongoing safety concerns.
This is a Class I recall, which means the FDA believes using these devices “may cause serious injuries or death.”
The Arrow QuickFlash Radial Artery and Radial Artery/Arterial Line catheterization kits are designed to give clinicians access to a patient’s peripheral arteries and other blood vessels. This recall is due to reports of “increased resistance” in the guidewire handle and chamber of the devices during use.
“This issue may cause serious injury, including injury to blood vessel walls, narrowing of the blood vessels (vasospasm), artery blockage (embolism) or death,” according to the FDA advisory.
Arrow International has received 194 complaints about this ongoing issue. It has been associated with 10 injuries and one patient death. This impacts a total of 334,995 catheter kits. They were distributed to customers from December 2021 to January 2024.
An Urgent Medical Device Recall was sent to all customers on Feb. 12, 2024. Arrow International recommends that healthcare providers immediately check their inventory for these devices and quarantine any they find. The impacted catheterization kits should not be used on any patients going forward.
A full list of product codes included in this Class 1 recall is available here.
A history of device recalls for Arrow International, Teleflex
Interventional devices distributed by Arrow International and Teleflex have been included in multiple FDA recalls in recent years. In November 2023, for example, nearly 2,000 catheter kits were recalled due to a labeling issue; the device was coated in chlorhexidine, but the product code and product name suggested otherwise. While sixteen incidents were reported due to this labeling mistake, no injuries were reported.
In July 2023, meanwhile, more than 250,000 catheters were recalled due to reports of device separation and leakage. There were 83 customer complaints about that issue, including 18 reported injuries.
Also, in December 2022, the companies recalled more than 2,000 intra-aortic balloon pumps due to significant battery issues.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.