According to a release issued by the US Food and Drug Administration (FDA) Penumbra has recalled its 3D Revascularization device due to a wire material that may break or separate during use.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The FDA has stated that the lot numbers affected are C00644, C00645, C00646, C00717, with distribution dates from 15 May to 7 June, 2017 and manufacturing dates between 31 March and 28 April, 2017. One hundred and fifty-five 3D Revascularisation devices were recalled in the USA.
As part of the Penumbra System, the Penumbra 3D Revascularization device is intended to restore blood flow or remove thrombus within a blood vessel in the brain during an acute ischaemic stroke in patients who are ineligible for or fail intravenous tissue plasminogen activator (IV t-PA) therapy.
According to the FDA, Penumbra is recalling the Penumbra 3D Revascularization device because there is a risk of the delivery wire breaking or separating during use. Fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse. This can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death.
On 9 June, 2017, Penumbra sent an Urgent Voluntary Removal notice to all affected customers. The notice asked customers to identify and remove any affected 3D Revascularization devices from inventory and quarantine.
Penumbra Inc. will contact customers directly to arrange return of affected units and replacement of returned product, free of charge.