Transseptal Guiding Sheath Kit Recalled

The FDA issued a Class 1 recall of the TorFlex Transseptal Guiding Sheath Kit, a “single use device designed for safe and easy catheterization and angiography of specific heart chambers and locations.” According to the Agency, “[t]he sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patient’s bloodstream.” Read the full FDA alert.


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