# Major Recall Alert: GORE® ACUSEAL Vascular Graft Recalled Due to Risk of Delamination
On **August 19, 2025**, a critical recall was issued for the **GORE® ACUSEAL Vascular Graft**. This important medical device, designed to aid in vascular graft procedures, has been found to carry a serious defect. Its layered design faces risks of **delamination**—the separation of its internal layers—which could lead to separated material protruding into the lumen. This defect may compromise the graft's functionality, impacting patient safety. Stay informed about this recall and understand the necessary steps to protect yourself or loved ones.
## Why This Recall is Important
The **GORE® ACUSEAL Vascular Graft** is an essential product for those requiring vascular intervention. However, the **delamination risk** could cause significant complications:
- **Protrusion into the lumen**: This can limit or block blood flow.
- **Increased procedural risks**: Surgery or medical intervention becomes more challenging or unsafe.
- **Potential health hazards**: If undiagnosed, the defect could result in long-term vascular complications.
Recalls like this are issued to safeguard patients and healthcare practitioners who rely on the proper function of these devices. The investigation into this issue has also revealed that the **Instructions for Use (IFU)** need to be updated to provide clearer guidelines regarding risks of delamination and the techniques that may inadvertently contribute to it.
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## Details of the Recall
Below are the key elements regarding **GORE® ACUSEAL Vascular Graft** and why it has been recalled:
- **Category**: Medical Device
- **Brand**: GORE®
- **Product**: GORE® ACUSEAL Vascular Graft
- **Recall Reason**: Risk of delamination, where separated material could protrude into the lumen and affect device performance.
- **Recall Start Date**: August 19, 2025
- **Issue Identified**: Updated guidelines in the Instructions for Use (IFU) are necessary to inform users about specific risks and proper techniques to prevent delamination.
This recall affects healthcare professionals and patients who depend on the durability and reliability of vascular grafts during critical medical procedures.
For more details, you can read the **official recall notice here**: [GORE® ACUSEAL Vascular Graft Recall](https://recalls-rappels.canada.ca/en/alert-recall/gorer-acuseal-vascular-graft).
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## What You Should Do
If you or someone you know has used or currently relies on the **GORE® ACUSEAL Vascular Graft**, it’s vital to take action immediately:
- **Contact Your Healthcare Provider**: Discuss any concerns about previously implanted vascular grafts or upcoming procedures that may involve this device.
- **Adhere to Updated Guidelines**: Healthcare providers should reference the revised **IFU guidelines** once available to minimize risks.
- **Monitor Patient Health**: Patients with implanted devices should report any unusual symptoms, including reduced blood flow or vascular complications, to their healthcare provider promptly.
- **Stay Informed of Updates**: Manufacturers may release additional advisories regarding updated use instructions or device replacements.
For healthcare professionals: Stay up-to-date on alerts involving essential medical devices to ensure patient safety during procedures.
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## Stay Safe – Get Instant Recall Alerts
Safety recalls like this underline the importance of staying informed about the medical devices you rely on. Timely action can prevent serious complications and protect lives.
To ensure you never miss critical recall notifications like this, download our **Recall Alert App** today! With instant alerts tailored to your needs, you’ll be among the first to know about recalls in Canada, from medical devices to consumer products. Your safety is our priority—**download now and stay updated!**
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The recall of the **GORE® ACUSEAL Vascular Graft** serves as an important reminder of the need for continuous vigilance in medical device safety. By taking proactive measures, healthcare providers and patients can work together to mitigate risks and ensure better health outcomes. For additional details, check the [official recall notice here](https://recalls-rappels.canada.ca/en/alert-recall/gorer-acuseal-vascular-graft).
**Stay informed, stay safe!**