Last Updated on March 20, 2025 by The Health Master
Medical Device recall
The U.S. Food and Drug Administration (USFDA) has issued a medical device recall for “Medtronic’s Pipeline Vantage Embolization Devices” and classified it as “most serious.”
This important action comes after alarming reports of four patient deaths and thirteen injuries linked to the said device, which raises serious concerns with respect to public health.
What is the Pipeline Vantage Embolization Device?
The Pipeline Vantage Embolization device is used for the treatment of cerebral aneurysms by means of bulging in the artery walls of the brain.
These devices are inserted into blood vessels via a microcatheter and deployed at the aneurysm site.
The braided tube, or “stent,” is used to obstruct blood flow to the bulging area and prevent rupture.
Device Failure and Patient Risk
Medtronic has started a medical device recall of the medical device due to a higher-than-expected incidence of the braided tube component failing to properly attach or remain attached to the blood vessel wall during and after procedures.
This malfunction can lead to incomplete wall apposition and braid deformation.
This is also called “fish-mouthing,” braid narrowing, or braid collapse.
These conditions can trigger severe complications, including:
- Thrombosis: Blood clot formation, potentially leading to blockages.
- Stroke: Disruption of blood flow to the brain, causing neurological damage.
The medical device recall is specifically for Pipeline Vantage devices compatible with 0.027” inner diameter microcatheters.
Medtronic has taken steps to medical device recall the affected medical device and has notified all the regulatory agencies worldwide.
Table: Summary of Medical Device Recall Information
| Feature | Details |
|---|---|
| Device | Pipeline Vantage Embolization Device |
| Recall Class | Class I (Most Serious) |
| Reason for Recall | Device failure (incomplete wall apposition, braid deformation) |
| Potential Risks | Thrombosis, stroke, death |
| Affected Devices | Compatible with 0.027″ inner diameter microcatheters |
| Target Demographic | Females, especially under 45 |
| Action Taken | Global recall, retrieval of affected products |
Q: What should I do if the Pipeline Vantage device is used in the procedure?
A: Immediately contact your healthcare provider and they will provide appropriate guidance.
Q: Where more information can be found about the medical device recall?
A: More information can be found on the USFDA’s website.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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