Nigerian News | NAFDAC Alerts Nigerians on the Voluntary Recall of JET 7 Catheters Due to Increased Risk of Mortality and Serious Injury

Pharmaceuticals
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The National Agency for Food and Drug Administration and Control has been intimated by 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.

The JET 7 Xtra Flex catheter and JET 7MAX configuration 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.

Following bench testing performed by the manufacturer, it shows 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 reportedly said that it 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.

Product Details

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

NAFDAC reportedly warn Nigerians to stop using the JET 7 Xtra Flex catheter, and healthcare facilities should remove and quarantine all unused affected products in their inventory.

The Agency reportedly ask the healthcare facilities to 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.

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About Nathaniel Adebayo 656 Articles
Nathaniel is a News Reporting Intern at Nigerian Law Intellectual Property Watch (NLIPW). He has a passion for writing, capacity building and social media marketing. He is a graduate of Federal University of Technology, Minna, where he graduated with BTECHAGRIC. He is a member of Soil Science Society of Nigeria (SSSN) and the National Union of Campus Journalist (NUCJ). Nathaniel has served as Editor-in-Chief for a number of magazines and as a contributor to various online repositories. Email: anathaniel@nlipw.com

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