Stryker ($SYK) is actively pursuing a Class I recall--the most serious--for its Neptune waste management system after one person died and another faced serious injury. Both faced tissue damage after using a particular product from the product line, which helps to drain fluid from the chest or body.
Other parts of the Neptune line are being recalled because they lacked the proper 510(k) clearance, Stryker acknowledged, so they were being sold without regulatory approval.
Stryker's recall covers the United States, Asia-Pacific region, Canada, Japan, Latin America, Europe, the Middle East and Africa. Recalled Neptune products include the Neptune 1 Gold Rover, Neptune 1 Gold Rover International, Neptune 1 Silver Rover, Neptune Bronze, Neptune 2 Rover Ultra (120V) and the Neptune 2 Rover Ultra (230V). The patient death involved use of the Neptune 2, the company said.
Stryker said it took initial action on June 5, and that action included only a handful of devices in the Neptune line. But the company expanded its recall effort on Sept. 18, notifying customers via FedEx overnight that it would also include the other Neptune iterations--the Neptune 1 Silver, Neptune 2 Ultra (120V) and the Neptune 2 Ultra (230V). These products will not be sold until they gain proper clearance, and regulators are advising clinicians and patients not to use them, Stryker disclosed.
The recall adds to the product woes for Stryker, which remains mired in lawsuits regarding its Rejuvenate hip implants. Patients are suing because they claim they suffered blood contamination from the recalled devices. Stryker recalled them globally in July, because of the risk of pain, swelling and device corrosion that could lead to heavy metal toxicity.