FDA MedWatch - JET 7 Catheters with Xtra Flex Technology by Penumbra: Recall - Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers

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 – Urgent Letter to Health Care Providers 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) due to 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 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 (such as vessel damage, hemorrhage, and cerebral infarction), and malfunctions such as vessel damage, hemorrhage, and cerebral infarction have been reported. Twenty of these MDRs describe 14 unique patient deaths, which include reports from different reporting sources for a single adverse event. 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 FDA is issuing this urgent letter to health care providers to ensure that health care providers and facilities are informed of this important recall. For more information about this recall click on red button "Read Recall" below. BACKGROUND: 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. Both catheters are component of the Penumbra System with the Penumbra Aspiration Pump and Penumbra Aspiration Tubing. RECOMMENDATION: 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. 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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