St. Jude Medical Recalls Introducer Device

The U.S. Food and Drug Administration (FDA) has issued a Class I recall of several St. Jude Medical 6 French Engage Introducer devices because its shaft or hub assembly may break and cause potentially fatal bleeding.

St. Jude Medical issued an urgent recall notice on June 24 warning of the hazard, including a field action notice advising sales representatives to visit sites using the affected products, according to a prepared statement from the FDA.

The Introducer device is used to implant catheters and electrodes into blood vessels and helps to prevent blood loss. The Engage Introducers, which are being designed to improve interventional procedures (from vascular access to closure), were approved in the United States and Europe in March 2010.

Included in the recall are several batches of Engage TR Introducer 6 Fr. ACT (2.25 mm) devices:

7 cm length, .025″ Max Guide Wire (batch# 3109782)
12 cm length, .025″ Max Guide Wire (batch# 3105838)
25 cm length, .035″ Max Guide Wire (batch# 3107645)
12 cm length, .035″ Max Guide Wire (batches 3103891, 3110889, 3118794, and 3123051)
12 cm length, .038″ Max Guide Wire (batches 3107789 and 3107790)

The recall affects about 5,120 devices produced between April 27 and June 3, 2010.

Healthcare professionals should stop using the affected devices, the FDA statement said.

St. Jude markets the Introducer devices through its Minnetonka, Minn.-based Cardiovascular (CV) product division, which deals with vascular closure devices. The CV division accounted for roughly 19 percent of the company’s total sales in second-quarter fiscal 2010.

FDA class I recalls affect products that may cause serious adverse events or death.