Levitronix Recalls CentriMag Extracorporeal Blood Pumping System

Levitronix has issued a Class I recall for its CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles. The defective medical device was distributed from the manufacturer in Switzerland to distributors world-wide including the United States. The company manufactured and distributed these products from January 2001 through March 2008.

Levitronix has issued the recall because use of the Valleylab Force FX-C or Valleylab SSE2L with the CentriMag Blood Pumping System may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.

The CentriMag Blood Pumping System (consisting of the blood pump and console) is used to provide short-term (up to six hours) extracorporeal (that is, outside the body) circulatory support during cardiac and other types of surgeries such as liver transplants. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure.

Levitronix issued a voluntary device correction letter on March 17, 2008, to its US distributor and requested that they contact their customers. On July 24, 2008, the firm updated their March 17, 2008, correction letter. The revised letter :

• informed their customers not to use Valleylab Force FX-C or SSE2L electrosurgery device with the firm’s CentriMag Blood Pumping System; and,
• included a new warning related to the use of the Valleylab device.