Clot removal devices for patients with stroke urgently recalled
The FDA announced that in response to its request, Penumbra has issued an urgent recall of reperfusion catheters for clot removal in patients with stroke due to risk for unexpected death or serious injury.
According to an alert from the agency, Penumbra has asked customers to stop using the devices and remove them from inventory.
The affected devices are the Jet 7 Xtra Flex catheter and the Jet 7Max configuration, which includes the Jet 7 Xtra Flex catheter and the Max delivery device. The Jet 7 reperfusion catheter with standard tip is not affected, according to the alert.
The FDA stated in the alert that it has received more than 200 medical device reports describing deaths, serious injuries or malfunctions associated with the devices. These include 20 reports of 14 deaths. Adverse events associated with the devices include vessel damage, hemorrhage and cerebral infarction, and device failure modes mentioned in the reports include ballooning, expansion, rupture, breakage/complete separation and exposure of internal support coils, according to the alert.
According to bench testing results, the products were not able to withstand the same burst pressures to failure as other large-bore aspiration catheters made by the manufacturer, the agency stated in the alert.
According to the alert, the agency asked Penumbra to issue a notification to health care providers, which it did July 27. The notification included immediate labeling changes such as a warning against using the device for contrast injection. After the notification was issued, medical device reports continued to be filed, and some incidents occurred because users had not started following the new procedures outlined in the notification, the FDA stated in the alert.
The FDA then asked Penumbra to remove the devices from the market, which it did via the urgent recall notice issued Tuesday, according to the alert.
Any events or suspected events associated with the device should be reported to the FDA via its MedWatch system, according to the alert.