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The maker of an angiographic catheter recalled the product because of debris in the lumen that may cause MI, stroke, limb ischemia, or death.
The high-speed injection feature of the Human Use High Injection Angiographic Catheter may increase the number of potentially lethal particles entering the bloodstream, according to a statement from device manufacturer Millar Instruments.
The recall includes 965 units sold internationally and 115 sold in six states -- California, Massachusetts, Michigan, Minnesota, New York, and Pennsylvania -- and the District of Columbia.
All devices with model numbers SPC-454D and SPC-454F are affected by the recall.
The FDA has been notified of the recall, the company said, although no adverse events related to the recall have been reported.
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Thursday, March 31, 2011
Medical News: Angio Cath Pulled for Particulate Debris - in Public Health & Policy, FDA General from MedPage Today
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