Millar Instruments, Inc. Issues a Recall of Millar Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F

Date of Recall

2011-03-22

Recall Details

- March 21, 2011 - Millar Instruments, Inc, Houston, Texas, is issuing a worldwide recall of 1,080 units of its Human Use High Injection Angiographic Catheter. The Angiographic Catheter, Models SPC-454D and SPC-454F, found to contain particulate debris within the catheter lumen, which potentially could result in embolization of foreign debris to tissues, vasculature, and organs, potentially causing myocardial infarction, stroke, limb ischemia, and /or death.

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 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, model numbers SPC-454D and SPC-454F, 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 7 states. These states are California, District of Columbia, Massachusetts, Michigan, Minnesota, New York, and Pennsylvania.

Millar Instruments, Inc. notified all distributors and customers by email and phone calls and arranged for return of all recalled products. Questions may be directed to the Millar Instruments at 1-800-669-2343 from 8:00 AM to 5:00 PM Central Daylight Time (CDT).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program by phone at 1-800-FDA-1088, by fax at1-800-FDA- 0178, by mail at MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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