Class One Recall for Intra-Aortic Balloon Catheters

The U.S. Food & Drug Administration (FDA) issued a Class One Recall for Intra-Aortic Balloon Catheters, a medical device. The balloon catheters are part of a larger medical device known as the Intra-Aortic Pump System. Arrow International manufactures the recalled devices; its parent company is Teleflex Medical. According to the FDA, a Class One Recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

The Intra-Aortic Pump System is designed to help cardiac patients by increasing the blood flow to the heart. The pumps provide cardiac assist therapy and the catheter is part of the overall pump system. The defect and the reason for the recall are the pump tubing and connectors. The blue connector in the intra-aortic balloon pump catheters is not properly recognized by the intra-aortic balloon pump system. This causes the volume setting on the pump to default to a setting of 2.5 or 5 cc. The correct pump setting should be 30, 40 or 50 cc volume.

Any change in volume is extremely serious and potentially life threatening for patients. When an incorrect volume is pumped, there may be little or no augmentation support. The intra-aortic balloon pump system becomes less effective and problems occur. In some patients, prolonged exposure to the low default volume can lead to organ failure, organ infarction (the organ issue dies because loss of blood supply) and death. In addition, prolonged exposure to a device that is only 1/3 full can result in systematic or cerebral thromboembolism (blood clots in the nervous system).

The recalled products were manufactured from January 2008 to January 2009 and were distributed from January 2008 to January 23, 2009. A total of 25 Arrow International has received complaints and that number is likely to increased in the coming weeks. However, as of now, there have been no reports of patient injury. The recall is worldwide and was initiated by the Arrow International’s Cardiac Care Division. Arrow International sent out an Urgent Medical Device recall letter to hospitals. Over 45,000 systems have been affected by the recall.

If you believe that you or a loved one has suffered from an Intra-Aortic Balloon Catheter, you may want to speak with an attorney regarding a potential lawsuit. Please CLICK HERE for a free consultation.