Intra-Aortic Balloon Pump Catheter Recall Issued by Arrow International

The FDA has classified an Intra-Aortic Balloon Pump catheter recall issued by Arrow International’s Cardiac Care Unit as a Class 1 recall, meaning that use of the product poses a reasonable probability of causing serious injury or death.

The recall was issued for volume connectors on the 30c, 40cc and 50cc Intra Aortic Balloon (IAB) catheters, as they could be faulty and cause the volume setting on the pump to default to 2.5cc or 5 cc. Prolonged exposure to the low default volume could cause severe organ injury or potentially result in patient death.

Approximately 45,211 units from 423 lots are affected by the recall, which was first initiated on February 6, 2009.

As of April 13, 2009, the FDA and Teleflex Medical, the parent company for Arrow International, were aware of at least 25 complaints involving this issue, but no reports of patient injury have been received.

The Intra-Aortic Pump System is used to increase blood flow to the heart of critically ill people by providing cardiac assist therapy and the IABP catheter is used as a component of the system.

When used by patients with low perfusion states or with moderate to severe myocardial ischemmia, the incorrect volume setting on the IABP catheter may not help improve the patients condition and could eventually lead to organ injury or death.

Extended exposure to a catheter which is inflated to less than 2/3 capacity could also result in the formation of thrombus on the Intra-Aortic Balloon and possibly lead to a cerebral or systemic thromboembolism.

Hospitals and distributors have been notified of the Intra Aortic Balloon Pump recall, which involves the recovering all unused products, issuing special instructions for reducing the risk of problems for patients in critical need and the replacement of pump tubing assemblies to correct the problem.

According to the manufacturer, the operator’s manual provides information about the necessary warnings and precautions that will identify the issue, which can allow the problems to be discovered immediately to prevent prolonged exposure to the low default volume.