Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

On 10/06/2022, Edwards Lifesciences sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx 2nd Day to customer informing them that certain lots of Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes are exhibiting latex deterioration in the balloon. It was determined that storage of these devices in the same room room as high energy ionizing radiation sources which can act as an ozone generator to the immediate environment, can accelerate latex deterioration and subsequent balloon failures. Advice on action to be taken by users: It is requested that they do not store Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes in rooms with high energy ionizing radiation sources that could generate ozone (e.g. Fluoroscopy machines, X-ray machines, UV lights, HVAC sanitation equipment, etc). Post the attached notification as a constant reminder to their staff of the issue. - If they have devices that have been exposed to the equipment described above, please return the affected inventory with the model and lot number referenced above. - If they have devices that have not been exposed to the equipment above (e.g. stored away from high energy ionizing radiation source), they may continue to use the devices per the IFU. Review their inventory and quarantine any exposed product until prepared for return to Edwards Lifesciences. Follow the instructions included in the enclosed customer acknowledgement form and return within 5 days of receipt of this notification. Edwards Customer Service 1-800-424-3278 from 5:00 a.m. to 4:30 p.m. PST.