St. Jude Medical, a healthcare products company based in Little Canada, Minnesota, announced that it had received Class I recall status from the United States Food and Drug Administration for its Amplatzer TorqVue FX device.
According to information from the company, St. Jude Medical recalled a specialized component used in the Amplatzer Occluder due to concerns that it could fracture. If this component of the delivery system fractures during use, patients could be exposed to an increased risk of serious injury or death.
St. Jude Medical’s Amplatzer Occluder is designed to treat patients suffering from patent foramen ovale. Patients with patent foramen ovale have a hole in the heart that does not close during normal human growth. In some cases, abnormal blood flow from one side of the heart to the other can increase a patient’s risk of stroke from blood clots.
In a formal notice posted on its website, the FDA stated, "[The recall] letter advised customers to stop using the device and remove it from their inventory." It continued, "St. Jude Medical plans to have their sales representatives perform site visits to assist with recall activities, including completion of the product reconciliation form and return of any unused product."
An FDA Class I recall is reserved for medical devices that pose a serious and immediate threat to patient safety and wellbeing.