# Major Recall Alert: BioFlo Dialysis Catheter With Endexo Technology Recalled Due to Design Defect
Merit Medical Systems, Inc. (Merit) has issued a **voluntary recall** for its **16F Dual-valved Splittable Sheath Introducer** after identifying a concerning design defect. The issue stems from the sheath introducer, which may fail to split as intended, posing serious risks to patient safety. This component is a critical part of several Merit devices, including the BioFlo Dialysis Catheter With Endexo Technology.
The defect has already led to reports of adverse events, including **patient injuries**. Inconsistent splitting can result in medical complications such as **hemorrhage**, **foreign bodies**, and **procedure delays**, raising significant safety concerns for device users.
Merit Medical urges customers to immediately cease using the affected sheath introducers and follow disposal guidelines.
## Why This Recall Is Important
Recalls of medical devices are not uncommon, but this specific recall is critical due to its potential implications for patient safety. The **BioFlo Dialysis Catheter With Endexo Technology** is widely used in medical settings, and a malfunction in its sheath introducer can have immediate and life-threatening consequences, including:
- **Hemorrhage**: Uncontrolled bleeding during or after catheter insertion.
- **Foreign Body Risk**: If the introducer fails to split, fragments may become lodged in the body, requiring additional medical intervention.
- **Procedure Delays**: Extended surgical or procedural time can increase risks for patients, especially those already in critical condition.
These risks underscore the urgency of Merit Medical’s recall and the need for health practitioners and facilities to act promptly.
## Details of the Recall
Merit Medical Systems has provided clear instructions regarding the affected product:
- **Product Name**: **BioFlo Dialysis Catheter With Endexo Technology**
- **Recalled Component**: Merit **16F Dual-valved Splittable Sheath Introducer**
- **Reason for Recall**: A design defect prevents the introducer from splitting as it should, causing potential harm.
- **Potential Patient Risks**: Hemorrhage, retained foreign bodies, and extended procedure times.
- **Customer Action Required**:
- Immediately discontinue using the **16F Dual-valved Splittable Sheath Introducer**.
- Dispose of the item directly at the point of use.
- Note that other products included with the sheath can still be used safely.
For additional details, visit the official recall announcement [here](https://recalls-rappels.canada.ca/en/alert-recall/bioflo-dialysis-catheter-endexo-technology).
## What You Should Do
If your facility uses the **BioFlo Dialysis Catheter With Endexo Technology**, follow these steps to ensure compliance and patient safety:
1. Stop using the **16F Dual-valved Splittable Sheath Introducer** immediately.
2. Locate and remove any remaining affected sheath introducers from your inventory.
3. Dispose of impacted components responsibly at their point of use.
4. Inform all staff and relevant departments about the recall to avoid further use.
5. Reach out to Merit Medical Systems for additional guidance or customer service assistance.
Patients and caregivers should also ask healthcare providers about possible exposure to the affected device and discuss any concerns.
## Stay Safe – Get Instant Recall Alerts
Your safety comes first, and staying informed is crucial. **Don’t risk missing important health alerts**. Download a trusted recall alert app today to receive instant updates on product recalls, including medical devices like the BioFlo Dialysis Catheter.
Being proactive can protect you from potential hazards. Don’t wait—equip yourself with the information you need. For the latest official details about this recall, visit the [Canadian Recall Page](https://recalls-rappels.canada.ca/en/alert-recall/bioflo-dialysis-catheter-endexo-technology).
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