The U.S. FDA issued an urgent alert 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 7 MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device) cleared under K191946 on February 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 December 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.
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.
- Complete Penumbra’s product identification / return form
- Contact Penumbra Customer Service ([email protected] or 1.888.272.4606), available Monday – Friday 7:30 AM to 4:00 PM PST, with any questions or concerns.
Report any adverse events or suspected events experienced with the JET 7 Xtra Flex through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
For more information, visit FDA.