Certain batches of the 6 French Engage Introducer a medical device used to implant catheters and electrodes into blood vessels during surgery to help prevent blood loss, are being recalled because the device’s shaft, or sheath, has the potential to separate from the hub or break in the hub assembly. If this were to occur during use, a potentially life threatening episode of bleeding could occur.
The product’s manufacturer, St. Jude Medical, identified the defect, which affects about 5,120 devices in batches produced between April 27 and June 3, 2010. The recall is classified as a Class 1, which is the most severe type of recall issued by the Food and Drug Administration (FDA) and is reserved for dangerous or defective products in which there is a reasonable probability for serious injury or death.
St. Jude Medical alerted customers about the recall and told them to stop using the affected devices. The manufacturer also advised sales representatives to visit the affected accounts and perform assigned tasks. Any questions about this recall should be directed to St. Jude Medical Cardiology Customer Service at firstname.lastname@example.org, 952-933-4700, or 888-864-7444.
Any adverse events with this or any other medical product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.