Medtronic's Pipeline Flex problems expand - Mass Device

Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, and Aug. 13, 2020.

According to an FDA release, Medtronic initiated the recall on July 13, 2021. There have been 59 reported device malfunctions, 10 serious injuries and two deaths related to the recall.

The company recalled the devices due to a risk of the delivery system's wire and tubes fracturing and breaking off when the system is in use to place, retrieve or move the stent inside a patient.

In an email to MassDevice, Medtronic spokesperson David T. Young provided the following statement on the recall:

In line with our commitment to safety and transparency, Medtronic has identified an opportunity to raise further awareness of a potential patient safety issue by voluntarily sending a letter to our physician users to notify them of voluntary recall for Pipeline Flex embolization device. Through investigation, we have established that the root cause of this delivery wire fracture is limited to a subset of devices. Although that recall did not affect Pipeline Flex devices with Shield Technology, the company recalled 822 total devices in the U.S., reporting 50 medical device reports with 10 related injuries and one related death.

Medtronic designed the Pipeline Flex device for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms from the petrous to the superior hypophyseal segments.


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