Catheters Recalled: May Crack and Injure Patients, FDA Warns

Catheters made by Endovascular, Inc. are being recalled today because the defective medical devices may crack and cause serious injury or death to patients, the Food and Drug Administration said.

The Trailblazer Support Catheter is inserted into a vein or artery through the skin to guide and support a wire into blood vessels and deliver solutions to patients. However, the recalled catheters may crack near the radiopaque marker band, which can cause insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and death.

The FDA has issued a Class I recall of the catheters, meaning the agency believes there is a reasonable probability that use of these products will cause serious adverse health consequences or death. A Class I recall is the most severe such product-safety action the FDA can issue.

The recalled catheters were manufactured from September 11, 2009 through September 29, 2009 and distributed from September 21, 2009 through October 27, 2009, the FDA said. Specific Model and Lot numbers are included in the recall. For a complete listing of the affected catheters, see the FDA’s recall notice.

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