According to the Complaint, Penumbra, Inc. is a global healthcare company that develops, manufactures and sells innovative medical devices for patients suffering from stroke and other vascular and neurovascular diseases. Penumbra was the first company to market aspiration catheters, a specialized catheter designed to remove blood clots from arteries and veins in stroke patients, in a surgical procedure known as a thrombectomy.
Until recently, one of the Company’s flagship products was the “Jet 7 Xtra Flex,” an aspiration. In mid-2020, concerns about the Jet 7 Xtra Flex’s safety began to emerge. Despite these concerns, Penumbra repeatedly assured investors during the Class Period that the Jet 7 Xtra Flex was “absolutely safe,” “exactly what we hoped it would be,” and “not a product that has any possibility of needing to be recalled.”
The Complaint alleges that during the Class Period, Defendants made false and/or misleading statements and/or failed to disclose material adverse facts about the Jet 7 Xtra Flex’s safety, as well as the Company’s business, operations, and prospects. Among other things, the Complaint alleges Defendants failed to disclose to investors: (1) that the Jet 7 Xtra Flex had known design defects that made it unsafe for its normal use; (2) that Penumbra did not adequately address the risk of Jet 7 Xtra Flex causing serious injury and deaths, which had in fact already occurred; (3) that the Jet 7 Xtra Flex was likely to be recalled due to its safety issues; and (4) as a result, Penumbra’s public statements as set forth above were materially false and misleading at all relevant times.