FDA recall: Penumbra’s JET 7 Catheters with Xtra Flex Technology
The U.S. Food and Drug Administration (FDA) alerted that Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious injury while used for removing clots in stroke patients.
All users should stop using this device, and facilities should remove these devices from inventory as directed in Penumbra’s Urgent Voluntary Medical Device Recall Notification.
The affected devices include:
· The JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.
· The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on Feb. 27, 2020.
This recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
The FDA has received over 200 medical device reports (MDRs) associated with the JET 7 Xtra Flex catheter, including deaths, serious injuries, and malfunctions. Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event. Other MDRs describe serious patient injury such as vessel damage, hemorrhage, and cerebral infarction. Device failure modes reported in the MDRs 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.
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.
On Dec. 15, 2020, the manufacturer (Penumbra) initiated a voluntary recall of all configurations of the JET 7 Xtra Flex from the market. The FDA is issuing this urgent letter to healthcare providers to ensure that healthcare providers and facilities are informed of this important recall.
FDA recommendations include:
· Follow all instructions provided in Penumbra’s Urgent Voluntary Medical Device Recall Notification
· Do not use the JET 7 Xtra Flex catheter
· Remove and quarantine all unused affected products in your inventory.
· Return the affected products to Penumbra in accordance with Penumbra’s instructions.
As a component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing, the JET 7 Xtra Flex catheter and JET 7MAX configuration (JET 7 Xtra Flex catheter and MAX Delivery Device) are medical devices intended to restore blood flow by removing clots using continuous aspiration in patients experiencing an acute ischemic stroke within 8 hours of symptom onset who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Following clearance of the JET 7 Xtra Flex catheter (K190010) and JET 7MAX configuration (K191946), the FDA has continued to monitor the postmarket safety and performance of the device.
The FDA prompted the manufacturer to issue a Notification to Healthcare Providers on July 27, 2020, with immediate labeling mitigations that included additional warnings, precautions, and instructions to mitigate risks associated with use of the device by healthcare providers. The 510(k) with the updated labeling (K202251) was cleared by the FDA on August 31, 2020 and included a warning against contrast injection through the device.
Since Penumbra’s labeling update and Notification to Healthcare Providers, the FDA continues to receive new MDRs related to the same device failure modes, including some reports where the updated instructions were not followed by healthcare providers. Because of the persistent risk, the FDA requested that Penumbra voluntarily remove the JET 7 Xtra Flex from the market to protect patients.
Penumbra has issued an Urgent Voluntary Medical Device Recall Notification notifying users of the removal of all configurations of the JET 7 Xtra Flex from the market. The FDA continues to work with the manufacturer on the voluntary recall. Patients who have been successfully treated with the device are not affected by this voluntary recall.