January 2, 2018: The first FDA medical device recall of 2018 is in already. The FDA hit Sterilmed, Inc., a Johnson & Johnson company, with a Class I recall of 112 “Agilis Steerable Introducer Sheath” heart devices. A Class I recall is the most serious recall issued by the FDA. It is issued in situations where a product or device may cause serious injury or death.
The Sterilmed heart device is used to insert and position various cardiovascular catheters in the heart. According to the FDA, the device is being recalled due to faulty valves which can cause blood to backflow during a procedure. This backflow is dangerous and could result in serious health consequences, including death.
All of the affected devices were manufactured and distributed between January 1, 2017 to May 5, 2017. Health care facilities have been directed to examine their inventories to determine if they have used the product. Patients who were treated with the defective device should be alerted and monitored.
If you are concerned that you may have been treated with this device, you should contact your healthcare provider and inquire. If you were treated with this device and suffered an adverse reaction, you should report the matter to MedWatch, FDA’s adverse event reporting system.
If you would like to speak to one of our highly skilled medical device team members, please call (877) 230-6690. An attorney and a medical professional evaluate each case and let individuals know what they believe the best course of action to be. All case evaluations and consultations are free and confidential.