Medical Device Safety and Recalls: Maquet Medical Systems, Tiger Paw System II - May Cause Tears and Bleeding in Heart Tissue

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Maquet Medical Systems, Tiger Paw System II - May Cause Tears and Bleeding in Heart Tissue

A recall has been issued for Maquet Medical Systems, Tiger Paw System II because the incomplete closure of the TigerPaw System II may result in tissue tears and/or bleeding, and for a possible tear on the left atrial wall (top left chamber) during use of the device.

The firm received 51 reports of adverse events and one death.

Use of this recalled device may cause serious adverse health consequences, including death.

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm446087.htm

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