Health Canada — Medical Devices · Canada · 2015-07-08 · Type II
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Reported risk: This recall is being initiated by COOK Medical due to reports received indicating the Introducing Dilator Component extends beyond the Introducer sheath further than intended and does not conform to the specifications. Potential adverse events that may occur as a result of the excess dilator length include difficulty in accessing the Hepatic vein, requiring additional manipulation, which could result in vessel injury.
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