March 23, 2011 - Millar Instruments Inc. is issuing a worldwide recall of 1,080 units of its Human Use High Injection Angiographic Catheter because they may contain particulate debris within the catheter lumen.
The debris found in some catheter, models SPC-454D and SPC-454F, potentially could result in embolization of foreign debris to tissues, vasculature and organs, potentially causing myocardial infarction, stroke, limb ischemia and/or death. ??
The U.S. Food and Drug Administration (FDA) said an investigation revealed that small particles may exist in additional catheters of these models. User feedback stated that particles entering the cardiovascular system increases when using the catheters’ high-speed injection feature. No injuries have been reported to date.
Millar elected to recall all catheters of these models as a precautionary measure. ?The recall includes all angiographic catheters that are not expired prior to March 2011. Millar customers and distributors who have unused catheters should return these catheters to Millar for inspection. ??
The firm voluntarily recalled the products after learning of the debris potential in these two models of catheters. FDA has been apprised of this action. ?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 seven states. These states are California, District of Columbia, Massachusetts, Michigan, Minnesota, New York, and Pennsylvania. ??
Millar Instruments, Inc. notified all distributors and customers by e-mail and phone calls and arranged for return of all recalled products. Questions may be directed to the Millar Instruments at 800.669.2343.
For more information: www.fda.gov/medwatch