Home » Penumbra Recalls Catheters Following Patient Deaths, Injuries
Penumbra Recalls Catheters Following Patient Deaths, Injuries
Devices Postmarket Safety
Penumbra has issued recalls for all configurations of its Jet 7 Xtra Flex catheter after the FDA received reports of 14 patient deaths and many serious injuries.
The FDA warned that the catheter poses a risk of death or serious injury when used to remove blood clots in stroke patients, noting that the agency has received more than 200 medical device reports that describe deaths and serious adverse events, including vessel damage, hemorrhage and cerebral infarction, from the device.
Bench testing performed by the manufacturer showed that the product “is not able to withstand the same burst pressures” as the manufacturer’s other large-bore aspiration catheters used to remove thrombus in acute ischemic stroke patients, the agency said.