Medical device manufacturer Penumbra has issued an urgent voluntary recall of the Jet 7 Reperfusion Catheter with Xtra Flex Technology over reports of significant patient injuries, including death. The Jet 7 Xtra Flex catheter and the Jet 7Max configurations are included in the recall action, but the Jet 7 Reperfusion Catheter with Standard Tip is not.
In a release that corresponded with Penumbra’s recall, the Food and Drug Administration stated that it had “received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions.” The agency went on to state that 20 of the MDRs were related to 14 patient deaths. Failures with the device included “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils” near the tip of the device. Testing indicated that the JET 7 Xtra Flex catheter can’t support the same pressures as other Penumbra devices “used to remove thrombus in acute ischemic stroke patients.”
Both Penumbra and the FDA have called for the complete stoppage of any usage of the device and for the devices to be removed from hospital inventories immediately.
Current problems with the Jet 7 are not a surprise development to Penumbra. The catheter’s label was updated in July of this year and another update was made just a month later. Neither update put a stop to the influx of medical device reports, however, and according to evtoday.com, the FDA requested that Penumbra issue a recall of the device voluntarily.
According to Penumbra, it is aware of at least one injury and one fatality that occurred after the July update to its label.