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Stryker Neptune Lacks FDA Approval, Recalled After Death

Stryker Neptune Lacks FDA Approval, Recalled After Death

September 27, 2012 — Styker Corp. and the U.S. Food and Drug Administration (FDA) are announcing an expanded recall of the Stryker Neptune Waste Management System. This medical device is used during operations to suck bodily fluids out of a patient and into a disposal system. Unfortunately, a fatal incident occurred when a doctor attached a patient’s passive chest tube to the high-powered, high-volume vacuum on the Neptune. The device lacks warnings about this risk. The recall is being expanded to include several Neptune systems that were never approved by the FDA before they were sold to healthcare professionals.

Stryker initially recalled one model of the Neptune on June 5, 2012, following two injury reports, including the one fatal incident. Stryker expanded the recall on September 18, 2012, after the FDA found that multiple waste management systems lacked clearance from the FDA. The additional recalled devices include the Neptune 1 Silver, the Neptune 2 Ultra, and a more powerful Neptune 2 Ultra.

According to a statement, the FDA has found that the devices are not “legally marketed because their safety and effectiveness have not yet been determined. As such, FDA advises that the devices not be used.”

Stryker must obtain clearance from the FDA under the 510(k) system before they can continue selling or marketing the devices. A 510(k) clearance allows manufacturers to gain approval for new devices that are based on existing devices. Until Stryker submits this application, the “FDA is therefore unable to determine whether these devices are as safe or effective as their legally marketed predicate.”

Not all of Stryker’s waste management systems are being recalled. The company has gained approval for most of its products. In October, customers who have the Neptune 1 Gold, Neptune 1 Gold International, or Neptune 1 Bronze will be sent a mailing that contains new warning stickers and instructions.

At this time, the FDA and Stryker advise that any customers who have the recalled products should stop using them. However, because there may be customers who lack any alternative, the risks and benefits should be carefully weighed. Stryker is requiring customers to obtain a Certificate of Medical Necessity if they wish to continue using the recalled products. This application must be submitted by October 12, 2012, and Stryker will respond by sending updated warnings and instructions

Stryker’s Neptune Waste Management System is a medical device that uses a high-powered vacuum to suck fluid waste out of a patient during an operation. The device minimizes the risk that healthcare professionals will be exposed to fluids or splashing during surgery. The device also has a disposal system that reduces the amount of waste and minimizes excessive handling of medical waste.

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