Teleflex Recalls Medical-Catheter Kit

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 [e-mail]

(END) Dow Jones Newswires

March 11, 2016 08:15 ET (13:15 GMT)

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