Stryker Corporation  issued a recall of its Neptune Waste Management System after the medical device allegedly caused serious injuries and death. The FDA categorizes the Stryker Neptune recall as a Class I, a class reserved only for medical devices that have been linked to death or permanent injuries.

The Stryker Neptune recall took the Neptune 1 Sliver and Neptune 2 Ultra Waste Management Systems off the market after several injury reports indicated the devices had caused serious injury including:

• Hemorrhaging
• Damage to soft tissue, muscle, and organs
• Death

According to the FDA, the agency began receiving reports of injuries and deaths related to the Stryker Neptune Waste Management System as early as August 2010.

However, Stryker reportedly did not notify the medical community until 2012, when the company initiated a Stryker Neptune recall. The FDA released its own public warning on October 5, 2012, giving the recall Class I status later in the month.

The Stryker Neptune recall was initiated after a patient reportedly died in 2012 as a result of a mishap with the Neptune Waste Management System. According to the documents, the Neptune System was attached to the chest tube during the patient’s lung removal surgery when the device reportedly malfunctioned and pulled the heart of its position, causing an aortic tear.

The FDA stated that “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.”

Overview of Stryker Neptune Waste Management System Allegations

The Stryker Neptune Waste Management System works by using a vacuum mechanism to collect and dispose of surgical fluids and waste, which build up during the surgery. This device is essentially a portable vacuum cleaner, which removes waste fluids and smoke emissions during medical procedures.

This device can do serious damage to the patient’s body if not properly used. The FDA stated that the alleged Neptune patient death was due to misuse of the device and failure of surgical personnel to follow the product’s safety instructions.

Stryker advises surgeons not to connect the device to a high power vacuum tube and to adhere to the device’s “revised instructions.” The company further advises customers of the Neptune Waste Management System to educate themselves of the complications associated with the device.

The FDA and Stryker initiated the Stryker Neptune recall in 2012, but injury reports continued to be submitted. A second death was allegedly linked to the Stryker Neptune Waste Management System in 2013. Other deaths have been reportedly linked to Stryker medical products.

Patients who have been injured by the Stryker waste management system may be able to file legal action against the medical device corporation. Potential claimants may benefit from a consultation with a knowledgeable medical device attorney to determine eligibility for a Stryker Neptune lawsuit.