The FDA has issued a Class 1 recall for Penumbra’s JET 7 Reperfusion Catheter because the tip can become damaged, which may result in severe injury or death.
On December 15, 2020, Penumba warned doctors to stop using JET 7 stroke catheters with Xtra Flex Technology after 14 patients died of major brain bleeding.
The FDA said it has received more than 200 reports of adverse events, including deaths, serious injuries, and malfunctions.
The problem is that the tip of the catheter can break off, or expand like a balloon inside the patient’s brain, causing catastrophic brain bleeding and sudden death.
JET 7 catheters are used in patients who are experiencing a stroke, according to the FDA.
The recall involves about 30,882 devices worldwide that were distributed between June 17, 2019 and December 14, 2020.
The FDA’s Class 1 recall is the most serious type of safety recall, reserved for devices that are likely to cause severe injury or death.
The recall follows months of criticism, including a November report from Quintessential Capital Management (QCM) calling the JET 7 a “killer catheter” that was rushed to market.
QCM warned that “the increased flexibility offered by the Jet 7 with Xtra Flex may have made it more prone to malfunction,” according to Bloomberg.
On December 8, 2020, QCM published another report claiming that some of Penumbra’s “scientific research pieces appear to have been authored by a fake individual.” Penumbra eventually confirmed that the research papers were actually written by Dr. Arani Bose, Penumbra’s co-founder and major shareholder.