Date Recall Initiated |
March 17, 2008 |
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Product: |
Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles (manufactured by Levitronix, GmbH, Zurich, Switzerland). The product is 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. |
Use: |
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. |
Recalling Firm: |
Levitronix, Inc. 45 First Avenue Waltham, Massachusetts 02451 |
Reason for Recall: |
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. |
Public Contact: |
Patients with questions or concerns may call Levitronix at 1-866-487-2837. |
FDA District: |
New England |
FDA Comment: |
Levitronix issued a voluntary device correction letter on March 17, 2008, to its U.S. distributor and requested that they contact their customers. On July 24, 2008, the firm updated their March 17, 2008, correction letter. The revised letter :
This recall action is an interim fix while the firm further investigates the source of the problem. For more information about this recall, please see the company’s website at : http://www.levitronix.com/Documents/Medical_us/Dear_Doctor-Final.pdf Healthcare professionals and consumers may report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.
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Updated August 4, 2008
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