Atherectomy Wires Recalled After 3 Failures, 1 Death, FDA Says

(November 30, 2015, 1:04 PM EST) -- SILVER SPRING, Md. — Boston Scientific Corp. on Oct. 9 issued an urgent recall of its RotaWire Elite atherectomy core wires after receiving three reports that the wires cracked and separated from the rest of the system, resulting in one death, the Food and Drug Administration reported Nov. 27.

The FDA said RotaWire Elite core wires that separate from the Rotablator Rotational Atherectomy System can cause serious injury such as tamponade (blood in the sac around the heart, causing decreased heath function), myocardial infarction (heart attack)...
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