Teleflex Medical Inc. (NYSE:TFX) subsidiary Arrow International issued a voluntary global recall of its 5800 Series intra-aortic balloon catheters with Super Arrow-Flex Sheath Introducer because of an increase of "stuck in sheath" reports.
The Food & Drug Administration classified the recall as Class I because there is a “reasonable probability” that the use of products could cause "serious adverse health consequences or death," according to the company.
“When the [intra-aortic balloon] becomes stuck in sheath, the user is unable to move the IAB catheter forward or backward, potentially causing a delay in critical therapy. Excessive manipulation of the IAB due to it becoming stuck in sheath during insertion may also result in excessive bleeding or arterial damage, significant vasospasm, prolonged tissue ischemia, tissue/vascular ischemia, injury, infarct, or death,” the company said in prepared remarks.
The recall covers products with the following codes: IAB-05830-U, IAB-05840-U, IAB-05830-LWS, IAB-05840-LWS, IAK-05845.
Teleflex expects a decrease of $2 million to $3 million in its consolidated revenue and 5 cents to 7 cents for its diluted earnings per share. The company expects the recall to push its anticipated revenue for 2011 down approximately $5 million to $6 million with a reduction in diluted earnings per share of about 6 cent to 8 cents, according to the company.