Stryker originally issued the recall in June, but expanded the motion to include additional models of the Neptune system after the FDA deemed the devices adulterated under U.S. law.
"Stryker notified customers via letter delivered by FedEx overnight delivery that it is expanding the recall on the Neptune 1 Silver, Neptune 2 Ultra (120V) and Neptune 2 Ultra (230V) because FDA has also advised Stryker that these devices require, but do not currently have, 510(k) clearance," according to the Stryker recall notice. "However, customers who do not have an alternative device to use should weigh the risks and benefits associated with continued use of these devices."
The recall includes the U.S., Asia Pacific, Canada, Japan, Latin America, Europe, the Middle East and Africa, according to the notice. Stryker has stopped distribution on all Neptune Rover systems until it can square things away with the FDA, the company added.
The Neptune devices collect and dispose of surgical waste during operations. The original recall, issued June 5, warned customers against connecting the Neptune systems to high-powered surgical sucking systems after 1 patient suffered tissue damage and died during such a procedure.
The FDA’s MAUDE adverse event reporting database contains 38 reports for the Neptune this year, although reporting is voluntary and is not considered a comprehensive account of incidents involving medical device defects. Most of the recent reports do not mention tissue damage associated with high-vacuum devices, but instead refer to overheating issues associated with the devices’ power plugs.
SYK shares slid 1% today, trading at $55.98 as of about 4:15 p.m.