Pipeline Flex Endovascular Flow Diverters Under Recall

Certain shipments of Medtronic intracranial aneurysm flow diverters are under class I recall due to the risk of delivery system fractures, FDA announced.

Used to treat brain aneurysms, Pipeline Flex and Pipeline Flex with Shield Technology devices were associated with push wire fractures in the delivery system during placement, retrieval, or movement of the devices.

The fractured pieces could be left in the patient’s brain bloodstream, and attempts to retrieve them could cause serious harm. Such fragments may ultimately result in stroke or death. There have been 59 reported device malfunctions, 10 serious injuries, and two deaths related to this problem, according to the FDA.

The recall applies specifically to Pipeline Flex devices distributed from April 18, 2019 to Aug. 13, 2020. Customers were notified in July that the devices should no longer be used and that any unused ones should be returned to Medtronic. The recall affects 8,825 devices in the U.S.

Last year, Pipeline Flex had been subject to a prior class I recall because of the same fracturing problem. That earlier recall affected models within a narrower distribution date range, and amounted to more than 800 devices.

Pipeline Flex devices are indicated for the endovascular treatment of certain wide-necked or fusiform intracranial aneurysms.

Pipeline Flex won FDA approval in 2015, and Pipeline Flex with Shield Technology was approved this April.