On December 15, the U.S. Food and Drug Administration (FDA) issued an Urgent Letter to Health Care Providers advising users of the Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology to stop utilizing the device. On the same day, Penumbra initiated a voluntary recall of the JET 7 with Xtra Flex from the U.S. market due to the device’s susceptibility to distal tip damage during use.
According to Penumbra’s Urgent Voluntary Medical Device Recall Notification, use of the device has been associated to an increased risk of mortality and serious injury in stroke patients. As directed in Penumbra’s Recall Notification, all users should stop using the device and facilities should remove it from their inventory. The company estimates that approximately 30,000 units of the recalled device have been distributed, and of those units, 17 events involving patient injury and 14 events involving patient death have been identified.
According to the FDA, device failures reported include “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 XTRA Flex catheter,” leading to various serious injuries like blood vessel damage, hemorrhage, and cerebral infarction.
The 2018 Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology is a medical device intended to restore blood flow by eliminating clots via continuous aspiration in patients experiencing an acute ischemic stroke. The device enables physicians to use minimally invasive aspiration to remove stroke-causing blood clots from the brain safely and effectively.
The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 XTRA FLEX including malfunctions, serious injuries, and 14 patient deaths associated with use of the device. Those who experienced major complications or death as a result of the use of a faulty Penumbra JET 7 Reperfusion Catheter may be entitled to monetary compensation for their damages.