A Maryland medical device manufacturer pleaded guilty to charges surrounding its wound dressing product, the Department of Justice said.
ACell pleaded guilty June 11 to failing to report issues surrounding its MicroMatrix product. Federal officials allege that in 2012, ACell removed MicroMatrix from hospitals, healthcare centers and sales inventories due to a health risk related to the device. The health risk was endotoxin contamination, which can cause fever, infection, septic shock and death.
ACell admitted it learned in January 2012 more than 30,000 MicroMatrix devices were contaminated with high endotoxin levels, prompting the removal. The company admitted to veiling the removal from Justice Department and healthcare officials.
In addition to the guilty plea, ACell agreed to settle allegations of submitting false claims to federal healthcare programs for MicroMatrix. The devicemaker agreed to pay $15 million to resolve its criminal and civil liability.
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