Risk Information

CANNULA INDICATIONS FOR USE: The AngioVac Cannula is indicated for use as a venous drainage cannula and for removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to six hours.

 

CIRCUIT INDICATIONS FOR USE: The AngioVac Circuit is indicated for use in procedures requiring extracorporeal circulatory support for periods of up to six hours.

 

CONTRAINDICATION: Do not use if the patient has severe arterial or venous vascular disease. The device is contraindicated in the removal of fibrous or calcified material (e.g., atherosclerotic plaque). The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.
WARNING: Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilizing may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilizing may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. Alone, this cannula is not a medical treatment device.

 

 

 

 

 

 

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