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FDA > CDRH > Medical Device Recalls > Class 1 Recall: Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board)

Class 1 Recall: Levitronix CentriMag Extracorporeal Blood Pumping System; CentriMag Primary Console (with v200 Application Software On Board)

Date Recall
Initiated
 March 17, 2008
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 :

  • 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 .

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.

Updated August 4, 2008

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