FDA MedWatch - JET 7 Reperfusion Catheter by Penumbra: Class I Recall - Due to Distal Tip Damage

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: JET 7 Reperfusion Catheter by Penumbra: Class I Recall - Due to Distal Tip Damage AUDIENCE: Patient, Health Professional, Risk Manager, Neurology  ISSUE: Penumbra recalled the Penumbra JET 7 Xtra Flex because the catheter may become susceptible to distal tip damage during use. 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. 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. This recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip. RECOMMENDATIONS: On December 15, 2020, Penumbra sent an Urgent Medical Device Recall notification to all affected customers with the following instructions: Share the recall notification with all users of the product within your facility to ensure that they are also aware of this recall. Immediately review your inventory for the specific catalog numbers listed in Penumbra's Urgent Voluntary Recall Notice. Remove all units from inventory and place them in quarantine for return to Penumbra, Inc. Complete and return the product identification / return form provided by Penumbra within three business days. 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.

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