Dive Brief:
- Teleflex has recalled nearly 335,000 catheterization kits from the U.S. after discovering an issue linked to 10 injuries and one death, the Food and Drug Administration said Wednesday.
- The company asked customers to quarantine Arrow Quickflash Catheterization Kits in February in response to reports of increased resistance in the guidewire handle and chamber during use.
- The FDA categorized the recall as a Class I event because the issue could cause serious injury such as damage to blood vessel walls, narrowing of the blood vessels, artery blockage or death.
Dive Insight:
Teleflex sent an urgent field safety notice to tell customers about a potentially defective component in kits that allow healthcare professionals to access a patient’s peripheral arterial circulation or other small vessels. The resistance of the guidewire could lead healthcare professionals to make multiple arterial punctures during repeated attempts to access vessels.
Healthcare professionals would detect the component issue if they tested kits “prior to use as directed by the information for use and good clinical practice,” Telexflex said. Even so, the company asked users to quarantine and return the affected products.
In its February notice, Teleflex said it had received 194 complaints reporting resistance of the guidewire handle/chamber during use as of Jan. 31. None of the complaints reported injury, the company said.
On Wednesday, the FDA said Teleflex reported 194 complaints, including 10 injuries and one death.
The recall is the latest in a series of quality issues related to Arrow products, which Teleflex acquired in a $2 billion deal in 2007. Over the past year, Teleflex has recalled Arrow products because of “mislabeling regarding the presence of chlorhexidine” and complaints about separations and leakage. The FDA categorized both of the earlier recalls as Class I events.
Teleflex CEO Liam Kelly said on an earnings call in February that the Arrow Endurance Extended Dwell Peripheral Catheter System recall, which began in May 2023, was a driver of the decline in constant currency vascular access sales that the company reported in the fourth quarter. Kelly added that “vascular will be a little bit lighter in the first quarter just due to the recall.”