Teleflex Recalls Medical-Catheter Kit
12 March 2016 - 12:30AM
Dow Jones News
Teleflex Inc. said Friday that it was recalling a
medical-catheter kit used in heart patients after six serious
injuries and one death.
The recall of 47,140 units distributed to hospitals and
treatment centers throughout the world began Feb. 9. The Wayne,
Pa., company provided more details Friday after the Food and Drug
Administration classified the recall as a Class I recall, the most
serious type. According to the agency, a Class I recall means there
is a "reasonable probability" the use of the product will cause
"adverse health consequences or death."
The device, known as Arrow intra-aortic balloon catheter kits,
is inserted into the aorta, the body's main artery, and provides
mechanical support for cardiac patients by inflating at different
phases of the cardiac cycle to increase heart output and reduce the
heart's workload.
The company said the sheath body may separate from the sheath
hub, resulting in potentially significant blood loss.
At the time of the recall, there were 13 adverse events with the
medical device, including six serious injuries and one death.
Teleflex makes medical devices under a number of brands
including Arrow, Deknatel and Hudson.
Shares, which have risen 14% in the last three months, were
inactive in premarket trading.
Write to Austen Hufford at austen.hufford@wsj.com
(END) Dow Jones Newswires
March 11, 2016 08:15 ET (13:15 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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