# Major Recall Alert: Relay®Pro Thoracic Stent-Graft System Recalled Due to Potential Life-Threatening Issues
The Relay®Pro Thoracic Stent-Graft System, a well-known medical device from Bolton Medical, has been officially recalled. The recall was initiated after post-market surveillance identified critical issues with the delivery system. Specifically, the graft may be unable to unclasp because the proximal clasp disconnects from the outer control tube. This defect poses serious risks, including fatal complications during medical procedures. Read on to understand the details, the dangers, and what steps to take if you’re affected by this recall.
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## Why This Recall is Important
Medical recalls are not taken lightly, as they involve the health and safety of patients who rely on these devices for life-saving procedures. In this case, the failure mode of the delivery system has led to devastating outcomes:
- **Four reported complaints** related to the defect.
- **Three fatalities**, including one due to aortic perforation.
- **Two deaths** following conversions to open surgery, with strokes being the fatal complication.
These life-threatening incidents emphasize the importance of immediate action for healthcare professionals, patients, and caregivers involved in procedures using the Relay®Pro Thoracic Stent-Graft System.
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## Details of the Recall
Bolton Medical initiated this recall based on its findings during routine post-market surveillance. Here are the key details to note:
- **Affected Product**: Relay®Pro Thoracic Stent-Graft System
- **Brand**: Relay®Pro
- **Issue**:
- Graft unable to unclasp from the delivery system due to proximal clasp disconnection.
- Lack of resistance when sliding the apex holder back, with failure to release the proximal stent.
- Implant cannot be recaptured once this issue occurs during the procedure.
- **Reported Outcomes**:
- Four complaints.
- Three deaths, including one aortic perforation, and two fatalities from stroke following conversion to open surgery.
- **Date Announced**: October 2023
Healthcare professionals are urged to recognize the signs of this failure mode during procedures and take precautionary measures to ensure patient safety.
[Read the official recall notice here for more details.](https://recalls-rappels.canada.ca/en/alert-recall/relayrpro-thoracic-stent-graft-system)
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## What You Should Do
Health professionals and patients must act promptly to minimize potential risks. Below are actionable steps for those affected:
1. **Healthcare Providers**:
- Immediately stop using any units of the affected product.
- Follow the manufacturer’s guidelines for safely handling unused devices.
- Contact Bolton Medical or local representatives for further instructions.
2. **Patients**:
- Verify with your healthcare provider if the Relay®Pro Thoracic Stent-Graft System was used in your procedure.
- Discuss alternative treatment plans with medical professionals if necessary.
- Monitor your health and report any unusual symptoms immediately to your doctor.
3. **For Compliance and Clarifications**:
- Reach out to Bolton Medical’s support for additional guidance.
Ignoring these steps could put lives at risk, so it’s vital to act urgently if you’re affected by this recall.
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## Stay Safe – Get Instant Recall Alerts
Staying updated on critical recalls like this one can save lives. By taking proactive measures and keeping informed, you can help ensure the safety of yourself and your loved ones.
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**Final Words**
Medical device recalls like the Relay®Pro Thoracic Stent-Graft System highlight the need for vigilance in the healthcare sector. By acting quickly and following safety protocols, we can minimize risks and prevent further tragedies. Don’t wait—stay informed and spread awareness.
For more information on this recall, visit the [official recall notice page here](https://recalls-rappels.canada.ca/en/alert-recall/relayrpro-thoracic-stent-graft-system).