TorFlex Transseptal Guiding Sheath Kits Recalled Over Injury Risk
TorFlex Transseptal Guiding Sheath Kits are being recalled by Baylis Medical because of a potential patient injury hazard. These devices, which are composed of a dilator, a guidewire, and a sheath, are supposed to allow for a medical professional to conduct a heart chamber catheterization and an angiography. It’s the sheath and the dilator that reportedly pose the defect, as a particulate smaller than five millimeters in size could apparently be dislodged from the dilator by the sheath. When that happens, said particulate could make its way into the individual’s bloodstream, which poses an injury risk to that patient. These products should be quarantined by medical professionals as soon as possible, and any instances of adversity ought to be reported to the company and to MedWatch.
Click here for more about the recall.