Millar Instruments, Inc. issued a worldwide recall for 1,080 units of its <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Human Use High Injection Angiographic Catheter after the devices were found to contain particulate debris within the catheter lumen. According to the recall notice, this potentially could result in embolization of foreign debris to tissues, vasculature, and organs, potentially causing myocardial infarction, stroke, limb ischemia, and /or death.
The recall involves Human Use High Injection Angiographic Catheter Models SPC-454D and SPC-454F that are not expired prior to March 2011. A total of 965 Catheters of SPC-454D and 454F were distributed to Millar international distributors and 115 catheters were distributed to Millar customers in California, District of Columbia, Massachusetts, Michigan, Minnesota, New York, and Pennsylvania.
Investigation revealed that small particles (debris) may exist in additional catheters of these models. User feedback stated that particles entering the cardiovascular system increases when using the cathetersâ€™ high speed injection feature. No injuries have been reported to date, and the recall is being characterized as precautionary.
Millar Instruments notified all distributors and customers by email and phone calls and arranged for return of all recalled products. Millar customers and distributors who have unused catheters should return them to Millar for inspection. Questions may be directed to Millar Instruments at 1-800-669-2343 from 8:00 AM to 5:00 PM Central Daylight Time (CDT).
Millar Instruments said in its recall notice that it has informed the U.S. Food & Drug Administration about this recall.