| Reason for the Action |
Specific lots of Venclose RF Ablation Catheters may have been manufactured with internal wiring errors. This error in wire configuration would allow inaccurate temperature detection and may result in devices reaching temperatures higher than intended, while the user receives incorrect warnings that the catheter has not reached temperature.
BD has also received customer complaints which include the following:
Mis-Wiring Problem:
The internal wiring error associated with the Venclose RF Ablation Catheter may result in excessive heat that could cause the following problems, potentially requiring additional medical care should they occur: heat-induced injury to nerves, skin burns, difficulty removing the device, damage to treated vessels or adjacent vessels, endothermal heat-induced thrombosis, deep vein thrombosis, pain, skin discoloration, or embolism of device components. Thrombosis and embolism of device component components could lead to pulmonary embolism.
Battery Power Problem:
Undistributed catheters from lots with potential crossed wires underwent additional inspection to ensure this problem was not present. In some instances, during this inspection, battery tabs became crinkled when reinserted. This may result in catheters arriving nonfunctional due to a lack of battery power. Potential health hazards include a delay to care and discomfort with minor injury. |