Medtronic Initiates Class I Recall of Pipeline Vantage Embolization Devices Following 4 Deaths and 17 Injuries

• Recall Scope

Immediately discontinue use and recall all Pipeline Vantage 027 model devices;

Update the instructions for use of the Pipeline Vantage 021 model device.

• Instrument Usage

Medtronic's Pipeline Vantage Embolization Device, featuring Shield Technology, is used for treating brain aneurysms. This endovascular interventional device is implanted through a minimally invasive catheter and delivers a braided tube to the aneurysm site to obstruct blood flow.

• Reason for Recall

Reports of failure or inability to maintain adherence of the flexible braided tube portion to the vessel wall during and after the use of related instruments (incomplete adherence and/or deformation of the braid) have significantly increased;

Possible risks include: incomplete apposition, stent deformation (also known as "fish-mouth deformation"), stent narrowing or collapse;

Women (especially those under 45) are at higher risk;

Use of the affected device may lead to serious health consequences, including blood clots, stroke, or death.

• Consequences

Pipeline Vantage 027 Model: Reports 13 Injury Events and 4 Deaths.

Pipeline Vantage 021 Model: Report four injury incidents, no fatalities.

• Medtronic Solutions

Immediately discontinue the use of Model 027 devices and return all unused inventory;

Be sure to read the updated operation instructions before using the 021 model instrument;

The updated instructions aim to optimize device size selection and stent braiding release techniques to reduce risks.