Pentax Pays $43M For Not Filing Device Reports, Shipping Outdated Instructions

Mealey's (April 20, 2020, 11:36 AM EDT) -- CAMDEN, N.J. — Medical device maker Pentax Medical Co. on April 1 agreed to pay $43 million in a criminal fine and forfeiture for shipping duodenoscopes to health care providers without approved cleaning instructions and for failing to timely report adverse events associated with its devices, according to a deferred prosecution agreement (DPA) with the U.S. attorney for the District of New Jersey (United States v. Pentax of America, Inc., et al., No. 20-mj-2054, D. N.J.)....