A type of catheter used during medical imaging procedures known as angiograms is being recalled by the manufacturer because there may be small particles inside the catheter that may cause life threatening health problems. The Class 1 recall involves the Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F, made by Millar Instruments Inc.

The devices were distributed between March 1, 2009 and February 28, 2011. Class 1 recalls are the most serious type of recall the Food and Drug Administration (FDA) can give and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The Mikro-Tip Angiographic Catheter is a device that measures pressure within the blood vessels. It is capable of delivering high-speed injection of material that is not absorbed into the body. This material is then used to view blood vessels.

The recall was initiated because small particles or debris was found inside the catheter. This foreign debris can potentially travel from the catheter to tissues, blood vessels, limbs and organs. This could lead to a decreased blood supply to these structures, which can result in serious injury or death.

Millar Instruments contacted its customers and distributors about the recall and instructed them to return the catheters to the company or report back if the catheters had been used. Consumers with questions regarding the recalled devices should call Millar Instruments at 800-669-2343 from 8 a.m. to 5 p.m. CDT.

Any side effects experienced after using this product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.