The US Food and Drug Administration (FDA) announced the urgent voluntary recall of Penumbra’s JET 7 catheters with Xtra Flex technology (JET 7 Xtra Flex) due to increased risk of mortality and serious injury. Penumbra initiated the recall on 15 December 2020.
This recall is due to where the catheter distal tip is plugged and pressurised. According to the FDA, the JET 7 Xtra Flex is not able to withstand the same burst pressures to failure as Penumbra’s other large bore aspiration catheters used to remove thrombus in acute ischaemic stroke.
This recall applies to the JET 7 Xtra Flex catheter, originally cleared 16 June 2019, and the JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX delivery device), originally cleared 27 February 2020. This does not apply to the Penumbra JET 7 reperfusion catheter with standard tip.
The FDA reports receiving 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. Penumbra report a total of 17 events involving patient injury, of the 30,000 distributed units. Other MDRs describe serious patient injury such as vessel damage, haemorrhage, 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.
The following instructions were provided as part of Penumbra’s urgent voluntary medical device recall:
- 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@example.com 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 programme