# Major Recall Alert: TorFlex™ Transseptal Guiding Sheath, VersaCross™ Access Solution, VersaCross™ Transseptal Sheath Recalled Due to Compromised Sterile Barrier Pouch
Boston Scientific has announced an urgent recall of specific lots of their **VersaCross™ Access Solution**, **TorFlex™ Transseptal Guiding Sheath**, and **VersaCross™ Transseptal Sheath**. This proactive measure, effective as of **June 10, 2025**, addresses a potential safety issue where a hole in the Tyvek layer of the sterile barrier pouch may compromise device sterility.
Healthcare providers and patients using these devices should be aware of the risks associated with this recall. Read on for a detailed breakdown and essential safety measures you must follow.
## Why This Recall Is Important
Ensuring the sterility of any medical device is critical, particularly when it is intended for use in procedures that involve penetrating the body. Boston Scientific identified a **potential hole in the Tyvek layer of the sterile barrier pouch** for specific lots of their **VersaCross™ Access Solution**, **TorFlex™ Transseptal Guiding Sheath**, and **VersaCross™ Transseptal Sheath**.
If sterility is compromised, the use of these devices could result in:
- Increased risk of infection.
- Possible delays or complications in medical procedures.
- Serious health implications for patients.
The recall affects only certain **specific lots of these devices**, and further details can be found in Boston Scientific's official statement (link included below). The company is taking immediate action to remove affected products from the market and advising customers on the necessary steps to ensure patient safety.
## Details of the Recall
Here are the key points to understand:
- **Affected Devices**:
- VersaCross™ Access Solution
- TorFlex™ Transseptal Guiding Sheath
- VersaCross™ Transseptal Sheath
- **Recall Reason**: A potential compromise in device sterility due to a hole in the Tyvek layer of the products' sterile barrier pouch.
- **Start Date**: June 10, 2025.
- **Brand**: Boston Scientific.
- **Risk**: The compromised sterile barrier poses a health risk, potentially leading to infections or complications during medical procedures involving the device.
Boston Scientific is reaching out to distributors, healthcare providers, and hospitals to ensure the affected lots are immediately removed from circulation.
For more comprehensive information, visit the official recall page here: [Boston Scientific Recall Alert](https://recalls-rappels.canada.ca/en/alert-recall/versacrosstm-access-solution-torflextm-transseptal-guiding-sheath-and-versacrosstm).
## What You Should Do
If you are a healthcare provider, patient, or distributor, here’s a step-by-step guide:
- **Check Inventory**: Review your stock for any VersaCross™ Access Solution, TorFlex™ Transseptal Guiding Sheath, or VersaCross™ Transseptal Sheath belonging to the affected lots.
- **Cease Usage**: Do not use products from the recalled lots.
- **Contact Boston Scientific**: Notify Boston Scientific immediately if you have identified any affected units. They will provide further instructions on how to handle impacted products.
- **Notify and Educate**: Inform all relevant staff, departments, or patients about the recall to prevent accidental use of these devices.
If you have questions or concerns, consult Boston Scientific directly or contact your local healthcare provider for guidance.
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**Call to Action**: Download a reputable recall alert app today to stay updated on vital medical device recalls and safety advisories. Early action can save lives.
For more information about this recall, visit the official page: [Boston Scientific Recall Alert](https://recalls-rappels.canada.ca/en/alert-recall/versacrosstm-access-solution-torflextm-transseptal-guiding-sheath-and-versacrosstm).
Your safety is our priority. Stay informed, act quickly, and remain vigilant with the latest updates.