FDA Recalls Defective Intra Aortic Balloon Pump (IAB) Catheters

Teleflex Medical and the FDA, as of April 15, 2009, notified healthcare professionals and hospital risk managers of the Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters. These devices are a component of the “Intra-Aortic Pump System” which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart. This recall is being conducted because a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.

The complete MedWatch Safety Summary, including a link to the FDA recall notice, can be found at: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Arrow.

Often a particular medical device has failed before. Yet the medical device industry continues to market and sell this very product. Accountability is the key. The medical device industry must be held accountable for the harm it imposes on the most fragile of our society - those that are sick, injured, and in need of help.

At Swartz & Swartz, P.C., we have a record of success in holding accountable those medical device manufacturers that promise the impossible at a knowingly hefty price-the consumer’s health, safety and sometimes life. Holding a medical device company accountable for the carnage it has knowingly caused is key to sparing the next patient unnecessary harm.

If you or a loved one has experienced serious injuries due to use of a Intra Aortic Balloon Pump (IAB) Catheter, contact the Boston law office of Swartz & Swartz, P.C..  We will answer your questions and protect your legal rights. Speak with a personal injury lawyer today by calling (617) 742-1900, or toll free outside of Boston, 1-800-545-3732.

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