Plymouth-based Ev3 Inc. has recalled several models of a catheter that may crack during medical procedures and cause serious injury, according to the Food and Drug Administration.
The federal agency said the recall of Ev3's Trailblazer support catheter was initiated Nov. 6, 2009, but the recall notice was posted on the FDA's website today.
The FDA, citing eight models and 27 lots of the Trailblazer catheter, gave the recall its most-serious designation -- Class 1 -- which means there is "reasonable probability that use of these products will cause serious adverse health consequences or death."
The FDA said the devices were manufactured from Sept. 11 to Sept. 29, 2009, and distributed from Sept. 21 to Oct. 27, 2009.
Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm196266.htm
