St. Jude Medical has issued a Class 1 recall of its 6 French Engage introducer devices, because some affected batches have the potential for separation of the shaft from the hub or for a break in the hub assembly. If either of these were to occur during use, a potentially life-threatening episode of bleeding could occur, according to the FDA.
The Engage introducer is used to implant catheters and electrodes into blood vessels during surgery and helps to prevent blood loss.
The St. Paul, Minn.-based company said the affected batches of the Engage introducer were produced between April 27 and June 3. The recall affects approximately 5,120 devices.
Customers were advised by the recalling firm to discontinue the use of the affected product.