Medical Device Safety and Recalls: Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems Labeling Issue

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

Title: Medical Device Safety and Recalls: Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems Labeling Issue

A recall has been issued for Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to a manufacturing error that caused the balloon inflation ports to be mislabeled. This may cause the physician using the device to deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs.  Depending upon the size of these clots, there is the possibility of serious patient injury or death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm433765.htm

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