Deans' stroke musings: Clot removal devices for patients with stroke urgently recalled

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Thursday, December 17, 2020

Clot removal devices for patients with stroke urgently recalled

Your responsibility to be cognizant enough in the ER to ask about this.

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.