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December 16, 2020
Penumbra Recalls Jet 7 Xtra Flex Stroke Catheter Due to Safety Concerns Including Potential Patient Injury and Death
December 16, 2020—Penumbra, Inc. yesterday announced the urgent voluntary recall of its Jet 7 Reperfusion Catheter with Xtra Flex Technology due to safety concerns related to distal tip damage susceptibility during use. The company says that distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage and subsequent patient injury or death.
The FDA also posted notice and details of the recall, stating that operators should stop using the device, which should be removed from inventory as directed by Penumbra.
Both the Jet 7 Xtra Flex catheter and the Jet 7Max configuration are affected, but the agency notes that the recall does not apply to Penumbra’s Jet 7 Reperfusion Catheter with Standard Tip.
The agency describes the issues related to Jet 7 Xtra Flex as follows:
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.
The FDA reports that Penumbra updated the labeling of the device and issued a Notification to Healthcare Providers in July 2020, and a 510(k) clearance with updated labeling warning against contrast injection through the device was issued in late August. However, device failure reports have continued, with FDA noting that some involve the updated instructions not having been followed. This prompted the agency to request that Penumbra voluntarily remove the product from the market.
Penumbra says it is aware of 17 events involving patient injury and 14 involving death, with one injury and one death known to have occurred after the July 2020 notification was issued.
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