FDA MedWatch - JET 7 Catheters with Xtra Flex Technology by Penumbra: Recall - Due to Increased Risk of Mortality and Serious Injury

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: JET 7 Catheters with Xtra Flex Technology by Penumbra: Recall - Due to Increased Risk of Mortality and Serious Injury AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: 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: 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. 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. For more information about this recall click on the red button "Read Recall" below. BACKGROUND: 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. RECOMMENDATIONS:  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 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. Patients who have been successfully treated with the device are not affected by this voluntary recall. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA