The U.S. Food and Drug Administration (FDA) has issued an urgent Class I recall of several batches of 6 French (6F) Engage Introducer devices of medical devices giant, St. Jude medical (STJ). The Class I recall is the most serious type of recall as it affects products, which can be potentially hazardous or even cause death.
The recall is based on the concern that the 6F Engage Introducer devices have the potential to cause fatal bleeding during their use. The FDA is apprehensive about the possibility of separation of the shaft from the hub or break in the hub assembly in these affected devices, which may lead to bleeding thereby, threatening life.
The Engage Introducers, which are being designed to improve interventional procedures (from vascular access to closure), were approved in the U.S. and Europe in March 2010. These devices are used to implant catheters and electrodes (electric conductors) into blood vessels during surgery and help prevent hemorrhage. According to St. Jude, the affected batches of the devices were manufactured between April 27 and June 3, 2010.
St. Jude issued an “Urgent Medical Device Recall Notice” on June 24, 2010, recommending its customers to cease using the affected Engage Introducer devices given their potential for life-threatening events. It also circulated a field action notice directing sales representatives to visit locations using these devices and executing the assigned tasks.
The recall affects roughly 5,120 Introducer devices. Healthcare professionals and consumers are advised to discontinue using the affected batches and are instructed to report adverse events or product quality issues to the FDA’s MedWatch Adverse Event Reporting program.
St. Jude markets the Introducer devices through its Cardiovascular (CV) product division which deals with vascular closure devices. The CV division accounted for roughly 19% of the company’s total sales in second-quarter fiscal 2010. Currently, we are Neutral on St. Jude.