Balloon catheters are in abundant use across the human vasculature. Thus, the January U.S. FDA draft guidance for angioplasty and specialty catheters captured a range of critical devices. However, ...
Cook Medical is recalling a percutaneous transluminal angioplasty (PTA) catheter due to problems associated with balloons bursting below the rated burst pressure. The US Food and Drug Administration ...
BLOOMINGTON, Ind.--(BUSINESS WIRE)--Cook Medical today further demonstrated its commitment to physician education through the launch of the Ciaglia Blue Dolphin Web site. Accessible through the Cook ...
The US Food and Drug Administration (FDA) has announced a recall of the Advance Enforcer 35 Focal-Force Percutaneous PTA Balloon Catheter 6 mm x 4 cm (Cook Inc), because of reports of the balloons ...