Penumbra has issued an urgent recall of its Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex). The FDA is issuing this urgent recall so health care providers and facilities are informed of the potential risk.
The urgency of this alert is due to a risk of unexpected death or serious injury while using the device. There have been over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex. This includes death, serious injury, and malfunction.
Twenty of the MDRs include 14 unique patient deaths. Some of the MDRs involve serious patient injuries such as vessel damage, hemorrhage, and cerebral infarction. Some of this is due to ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex.
According to the US Food and Drug Administration, “Bench testing performed by the manufacturer, where the catheter distal tip is plugged and pressurized to failure, demonstrates that the JET 7 Xtra Flex catheter is not able to withstand the same burst pressures to failure as the manufacturer’s other large bore aspiration catheters used to remove thrombus in acute ischemic stroke patients.”
All facilities should remove these devices from their inventory, as indicated in the Penumbra Urgent Voluntary Medical Device Recall Notification.
The devices involved in this recall are as follows:
- JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
- JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 27, 2020.
The JET 7 Xtra Flex and JET 7MAX configuration (which includes JET 7 Xtra Flex catheter and MAX Delivery Device) are components of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing. They are medical devices used to restore blood flow by removing clots.
The clots are removed using the continuous aspiration mechanism in patients who have experienced acute ischemic stroke within eight hours of symptom onset. These patients are also typically ineligible for intravenous tissue plasminogen activator (IV t-PA), or those who fail IV t-PA therapy.
The FDA issued a Notification to Healthcare Providers in July 2020 with additional warnings, precautions, and instructions that help mitigate risks associated with the devices. Another update was cleared in August 2020 that included a warning against contrast injection through the device.
As the FDA has continued to monitor these devices, some reports have come in that outline updated instructions over the summer of 2020 were not followed by health care providers. Due to the increased risk, the FDA requested a voluntary recall. The issue has now progressed to an urgent recall of these Penumbra devices.
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