Two serious injuries, including a death, have prompted a recall of the Stryker Neptune Waste Management System, a medical device that has never gained regulatory approval.
According to a Bloomberg report this week, medical device giant Stryker Corp. has been forced to issue a Class I recall on three models of its Neptune Waste Management System after receiving two reports of malfunctions that caused patients serious injury or death. A Class I recall indicates that use of that device is likely to cause serious injuries or death.
The Neptune Waste Management System is used during surgical procedures to collect fluid waste from the patient. In one of the incidents that prompted the recall, a patient’s passive chest drainage tube was connected to the Neptune 2 system, a model that features a strong vacuum and high flow. Due to complications during the surgery caused by the malfunctioning device, the patient died.
This Class I recall being issued by the company, which is an unusual move, is an update to a previous announcement from Stryker regarding defects and malfunctions with the Neptune systems. Bloomberg reports that initial communication from the company told health professionals that “that devices should not be connected to passive drainage tubes” and that warning was not included on safety labeling currently with the devices. In the updated recall statement from Stryker, customers were only first told that the Neptune 1 Silver and two versions Neptune 2 Ultra had never been approved for use by the Food and Drug Administration.
In the statement, Stryker admits that the FDA does not consider the Neptune waste removal systems to be safe or effective because it hasn’t approved them for use during surgeries. Prior to a medical device or other pharmaceutical product being released to the market, the manufacturer must have it endure extensive clinical testing to ensure its safety and effectiveness. The FDA is supposed to have time to review these studies for accuracy and potential conflicts-of-interest before giving it a final OK and putting it on the market.
As such, Stryker has ceased marketing and distributing the Neptune devices. Those who currently use them should seek an alternative device to use and if that’s not available, they should seek a certificate of medical necessity from the FDA to continue using it despite the lack of an approval.