The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT).
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. Fractured pieces could stay inside the patient’s brain bloodstream, while there is the possibility that attempts to retrieve the fractured pieces may worsen the patient’s condition. The fragments can also cause other serious adverse health consequences, including continued blockage of blood vessels, stroke and death.
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. Medtronic has implemented corrective actions.
Medtronic has received reports of delivery pushwire fracture
at the distal section of the Pipeline delivery system during use. Through investigation, we have established that the root cause of this delivery wire fracture is limited to a subset of devices. Corrective actions have already been implemented to address the underlying issue causing the delivery wire fracture
At Medtronic, patient safety is our priority. We take this potential risk seriously, and we are working to ensure all Medtronic customers are fully aware of the risk and associated mitigations.
In March 2020, Medtronic had another Class I recall for Pipeline Flex also related to device fracture. 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. In February 2019, it won expanded FDA indication for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.
In April of this year, Medtronic received FDA approval for the Pipeline Flex embolization device with Shield Technology for advancing flow diversion therapy through a surface-modified implant device that demonstrates a reduction in material thrombogenicity — a reduction in the tendency of the surface treatment material to create clots.
With the latest recall, Medtronic instructed customers to stop the use of any impacted product, with all unused impacted products to be quarantined immediately. Those products should eventually be returned to Medtronic and customers should contact a Medtronic representative for help with product returns or to identify a suitable replacement product if one is needed.