Sam Brusco, Associate Editor01.29.21
Penumbra’s JET 7 Reperfusion Catheter with Xtra Flex Technology (also known as JET 7 Xtra Flex) is the subject of a U.S. Food and Drug Administration (FDA) Class I recall. All lots have been recalled, with manufacturing dates taking place between May 10, 2019 and December 11, 2020. Distribution took place from June 17, 2019 to December 14, 2020. 30,882 devices were distributed total.
Penumbra recalled JET 7 Xtra Flex because the catheter was reported to be susceptible to distal tip damage during use. The FDA has received over 200 medical device reports, including malfunctions, serious injuries, and 14 deaths. Other reports describe vessel damage, hemorrhage, and cerebral infarction.
Device failures reported included ballooning, expansion, rupture, breakage or complete separation, and internal support exposure near the distal tip.
A component of the Penumbra System along with the Penumbra Aspiration Pump and Aspiration Tubing, JET 7 Xtra Flex and the MAX Delivery Device are intended to restore blood flow by removing clots using continuous aspiration in patients with acute ischemic stroke within 8 hours, who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or fail IV t-PA therapy.
This recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
Penumbra recalled JET 7 Xtra Flex because the catheter was reported to be susceptible to distal tip damage during use. The FDA has received over 200 medical device reports, including malfunctions, serious injuries, and 14 deaths. Other reports describe vessel damage, hemorrhage, and cerebral infarction.
Device failures reported included ballooning, expansion, rupture, breakage or complete separation, and internal support exposure near the distal tip.
A component of the Penumbra System along with the Penumbra Aspiration Pump and Aspiration Tubing, JET 7 Xtra Flex and the MAX Delivery Device are intended to restore blood flow by removing clots using continuous aspiration in patients with acute ischemic stroke within 8 hours, who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or fail IV t-PA therapy.
This recall does not apply to the Penumbra JET 7 Reperfusion Catheter with Standard Tip.
