Voluntary Recall of JET 7 Catheters with Xtra Flex Technology by Penumbra due to Increased Risk of Mortality and Serious Injury
December 30, 2020,
The National Agency for Food and Drug Administration and Control has received information from the US FDA 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) due to the risk of unexpected death or serious injury while being used for removing clots in stroke patients
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.
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.
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.
The affected devices include:
|Product Name||Catalog Number (REF)||UDI||Lot Numbers|
|Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing||5MAXJET7KIT||00815948020962||ALL|
|Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing||5MAXJET7L138KIT||00815948021594||ALL|
|Penumbra JET 7 Reperfusion Catheter||5MAXJET7||00815948020955||ALL|
- All users should stop using the JET 7 Xtra Flex catheter, and healthcare facilities should remove and quarantine all unused affected products in your inventory.
- Return the affected products to Penumbra in accordance with Penumbra’s instructions available at https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf or submit them to the nearest NAFDAC office.
Healthcare professionals are encouraged to report any adverse events or side effects related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLL FREE from all networks), via the MedSafety App or via firstname.lastname@example.org