The U.S. Food and Drug Administration (FDA) recently announced the Class 1 recall of Medtronic Pipeline Vantage embolization devices due to reports of 17 injuries and four deaths.
Doctors use these devices to treat bulges in the artery walls of the brain (aneurysms). A Class I recall is the FDA’s most serious type of recall, reserved for products with a reasonable probability of causing serious adverse health consequences or death.
Medical Devices Linked to Serious Injuries and Four Deaths
The recall involves two models of the Pipeline Vantage devices.
- Pipeline Vantage 027: Medtronic is removing these from where they are used or sold.
- Pipeline Vantage 021: Medtronic is updating the use instructions for these devices.
The company is conducting this recall because they’ve received reports of the device’s flexible, braided tube part failing to properly attach or stay attached to the blood vessel wall during and after procedures. The use of the 027 device or the improper use of the 021 device could cause serious adverse health consequences, including blood clots, stroke, and death.
At the time of the recall, the company had received reports of 13 injuries and four deaths related to the 027 device and four reported injuries related to the 021 device. As of the end of 2024, Medtronic had received 416 complaints about the 027 devices and 57 complaints concerning the 021 devices.
On January 30, 2025, Medtronic Neurovascular sent all affected customers an Urgent Medical Device Recall letter recommending that they stop using the Pipeline Vantage 027, remove and quarantine all unused affected products, and return them to Medtronic with the help of a Medtronic representative.
The letter also recommended downloading and reviewing the labeling updates for the Pipeline Vantage 021 device.
“The updates aim to help achieve optimal device size selection and stent braid deployment to reduce the risk of complications and patient harms by lowering the incidence of incomplete wall apposition and/or braid deformation,” the letter stated.
Medtronic Devices May Not Stay in Place as Designed
Medtronic’s Pipeline Vantage embolization devices were designed to treat bulges in the brain’s artery walls (aneurysms). They help redirect blood flow away from the aneurysm into the parent artery, allowing the aneurysm to clot off over time.
Healthcare providers thread a small catheter through the parent blood vessel, insert the Pipeline device into the catheter, and push it through to the aneurysm location. There, a small, braided tube is placed to block blood flow to the bulging area.
If the device fails to attach properly or becomes unattached later on, it can cause a blood clot, stroke, or death. According to the recall, the risks of these complications were higher in females, especially those younger than 45 years of age.
Both the 027 and 021 devices were reported to have problems, but because there were far fewer reports related to the 021 device, Medtronic is not recalling it, but simply updating the instructions that accompany it.
Previous Recall Affecting Medtronic Pipeline Aneurysm Devices
This isn’t the first time Medtronic devices have been recalled because of apparent defects. In September 2021, the company recalled nearly 9,000 Pipeline Flex embolization devices for brain aneurysms. Fractured pieces of the devices could be left inside the patient’s brain bloodstream. At the time of the recall, there had been 59 reported device malfunctions, 10 serious injuries, and two deaths.
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