Cook Medical this week released information on a select voluntary recall of its Bush DL and Bush SL ureteral illuminating catheter sets over issues with overheating.
The Bloomington, Ind.-based company said it has received an increased number of reports of the proximal black component that connects to the distal transparent component overheating and melting, which could potentially cause burns.
Cook Medical clarified that it has received no reports of any overheating along the transparent component of the catheter which comes into contact with the patients’ urethra, bladder and ureter.
The recall affects Bush DL cath sets with reference part numbers 084520, 084510 and J-BICS-078000, with GPNs of G16747, G16143 and G16262, and Bush SL caths with reference part numbers 084100, 084120 and J-BICS-058020 and GPNs G16745, G16746 and G16737.
The company advised any customers with affected devices to return the indicated products, according to an urgent field safety notice from the company.
Earlier this month, Cook Medical released an urgent safety notice warning of clot risks associated with its Zenith Alpha thoracic endovascular graft when used to treat blunt thoracic aortic injuries.
The company warned of a 25% observed rate of thrombus within the graft during follow-ups to a clinical trial evaluating the use of the device for treating BTAI, though none of the cases required an open surgical conversion or bypass. In past studies, the rate of thrombus within grafts ranges from 15% to 40%, the company said.