The U.S. Food and Drug Administration (FDA) has alerted consumers and health care providers to an urgent recall of all Penumbra JET 7 Reperfusion Catheters with Xtra Flex Technology. This product is being recalled from the market because of an increased risk of death or serious injury when the product is used to remove clots from patients who had a stroke.
The FDA is urging people to immediately discontinue use of those products. Medical facilities should also take these catheters out of their inventory, as they are directed to do in the Urgent Voluntary Medical Device Recall Notification issued by Penumbra.
The recall applies to the following products:
However, it is important to note the JET 7 Reperfusion Catheter with Standard Tip is excluded from this recall.
More than 200 medical device reports received by the FDA detail deaths, serious injuries and malfunctions. This includes 20 reports that detail 14 deaths. Some of the serious injuries that have been reported include:
There are also reports of device failure, including:
The manufacturer conducted bench tests involving the catheter tip being plugged and pressurized until it fails. These tests revealed the JET 7 Xtra Flex catheter was unable to withstand the same burst pressures as other large bore aspiration catheters that can be used to remove clots in stroke patients.
The FDA is recommending all instructions from Penumbra’s Recall Notification be followed. This includes removing and quarantining unused products and returning affected products to Penumbra.
The FDA will continue to inform the public about new or additional information relevant to these dangerous products and the recall.
On July 27, 2020, the FDA required Penumbra to issue a Notification to Healthcare Providers about more warnings, precautions and instructions to reduce the risk of using the JET 7 catheters that have now been recalled. Since then, reports about device failure have continued to be sent to the FDA. This led the FDA to ask Penumbra to voluntarily remove the device from the market.
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