Bard Peripheral Vascular Inc recalls POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate
Recalled Product
POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.
Hazard / Issue
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Issued by
FDA
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