A recalled medical device used to keep a cleaner surgical environment is accused of causing a Stryker Neptune injury in several patients.

The Stryker Neptune is a vacuum mechanism that collects and disposes of surgical fluids and waste from a patient during an operation. The Neptune has been linked to injuries and even one death.

Stryker recalled the Neptune 1 Gold Rover, Neptune Gold Rover International, Neptune 1 Silver Rover, Neptune Bronze, Neptune Rover Ultra (120V) and the Neptune Rover Ultra (230V).

Only the Neptune 1 Gold Waste Management System went through the full FDA approval process for new medical devices. The other versions never received FDA approval, apparently because Stryker claimed the new models were similar enough to the approved model.

The devices are intended to reduce the dangers to healthcare workers who might otherwise be exposed to contaminated medical waste.

Improperly trained medical personnel combined with incomplete directions have contributed to Stryker Neptune injury cases.

The FDA has issued a Class I recall, the most serious level possible, for the Neptunes.

Stryker Neptune Injury and Death Possible

One 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 suctioning caused the heart to be pulled from its position, creating a fatal tear in the aorta.

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.

“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,” says the FDA.

“When used incorrectly the Neptune 1 Silver and the Neptune 2 Ultra Waste Management Systems can cause hemorrhaging and soft tissue, muscle, and vital organ damage that can lead to serious injury and/or death,” according to the FDA’s summary of the Stryker Neptune injury risks.

The FDA warns the devices should not be used unless no other acceptable alternative is available.

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 now 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.

The FDA additionally warns medical providers to consider the type of tissue that will be affected by the use of the machine and to adjust the suction levels accordingly to reduce the possibility of a Stryker Neptune injury.

If you or a loved one have been a victim of a Stryker Neptune injury, you may qualify to participate in a Stryker Neptune lawsuit.