Bloomington-based Cook Medical is recalling more than 4 million catheters. The devices feature are primarily used for vascular catheterization to make it easier for doctors to see the tip of the catheter.
They’re being recalled because when the tip of the catheter breaks or cracks, it creates a risk that part of it could remain in the patient’s body.
Cook Medical Global Content Manager Marsh Lovejoy says the recall was voluntary.
“Once we better understand why it’s occurring and what’s causing that to happen, then we want to reintroduce them to the market so physicians have the product to use,” Lovejoy says.
Lovejoy says a lot of the catheters have probably already been used.
“However, if the product’s been used and there was no issue, patients don’t need to be concerned about that because any issue would have been found during the procedure,” she adds.
Last year, Cook recalled around a half million products with Beacon Tips. Cook plans to increase production of other catheters until the problem is resolved.