Cook Medical is recalling 360 lots of its single lumen central venous catheters, pressure monitoring sets and trays due to issues with catheter tip fracture and separation.

A total of 17,872 devices are subject to the recall, according to Cook, who said it began notifying customers and distributors of the issue in January and that it has contacted the FDA and other regulatory bodies over the issue.

The problem was discovered during an internal inspection, in which a catheter “exhibited the potential for catheter tip fracture and/or separation,” according to an FDA press release. Cook Medical said they investigated further and found the technique used by the assembler to attach the tip was likely at fault.

Cook Medical said there have been no reports of injury or illness associated with the issue, though potential adverse events could occur due to tip fracture or separation that would require medical interventions to retrieve the fractured or separated tips.

Such an event could result in occluded blood flow to end organs, with complications including stroke, kidney injury or damage to the intestines or limbs, the company said.

The devices were distributed internationally between April 24, 2015 and Oct. 23, 2015.

The recall affects multiple part, product and lot numbers. Included in the recall are Cook’s femoral artery pressure monitoring catheter tray, femoral artery pressure monitoring catheter set, radial artery pressure monitoring catheter tray, radial artery pressure monitoring catheter set, single lumen central venous catheter set, single lumen central venous catheter tray and single lumen pressure monitoring kit.

Cook Medical said customers and distributors should quarantine and discontinue use of all affected units, and return them to the company for credit.