A machine used as a surgical aid is the focus of a Stryker Neptune recall.

Sitting on a rolling cart, the Stryker Neptune uses a vacuum mechanism to collect and dispose of surgical fluids and waste. The Neptune has been linked to injuries and even one death.

The recall applies to the Neptune 2 Rover and the Neptune 1 Gold Rover, Silver Rover and Bronze Rover. These Stryker Neptune medical devices are used to keep a cleaner operating environment, reducing the dangers to healthcare workers who might otherwise be exposed to the medical waste.

Stryker Neptune Recall

A patient died during an operation in 2012 when the Neptune Waste Management System was attached to a chest tube during a lung removal. The Neptune’s suction caused the heart to be pulled from its position, creating a fatal tear in the aorta.

The Stryker Neptune recall was sparked by other incidents involving hemorrhaging and damage to soft tissue, muscle and organs.

The FDA reportedly started to receive reports of injuries and deaths that were related to the Neptune in 2010, but Stryker did not reach out to the medical community regarding potential issues until 2012 when the Neptune 1 and 2 machines were recalled.

Less than a month after Stryker issued its recall, the FDA classified the Stryker Neptune recall as a Class I Recall Notice, the most seriously ranked recall reserved for drugs and medical devices linked to serious injuries or death.

The FDA said it received still more reports of injuries and deaths as a result of the Stryker Neptune medical devices in 2013.

“The patient death and injury reports indicate that the high-flow, high-suction vacuum had been incorrectly applied, and were associated with users of the device who had not been properly trained on how to use the device,” according to the FDA.

Stryker says the patient who died was connected to a Neptune 2 waste management system via a post-operative passive drainage tube.

“The current (instructions) did not specifically warn against connecting the Neptune Rover, which is a high vacuum/high flow device, to a passive drainage tube,” Stryker said. “Customers were instructed to review the revised (instructions), distribute to affected departments, and educate users of the Neptune on this warning.”

Stryker’s website includes safety information that includes warnings for medical personnel not to use the device to provide suction on closed wound drainage systems or in post-operative situations.

Healthcare workers also are advised not to “apply high flow suction or allow extended exposure of suction to tissue associated with procedures that require either no suction, low vacuum or low flow suction, for example, passive chest drainage.”

If you or a loved one has been injured by the use of any of the devices in this Stryker Neptune recall, you may qualify to participate in a Stryker Neptune lawsuit.