# Major Recall Alert: Disposable Triple Lumen Sphincterotome, Sphincterotome Recalled Due to Performance Risks
Medical device manufacturer Olympus has announced a critical recall of its CleverCut and FlowCut sphincterotome devices, including the **Disposable Triple Lumen Sphincterotome** and **Sphincterotome** products. These devices, which are critical tools in certain medical procedures, may present serious risks if used. Certain lots were found to have skipped the thermoforming process during manufacturing, causing potential deformation and compromised product performance. This recall affects healthcare providers and facilities relying on these tools for precision and reliability.
If you or your institution uses CleverCut or FlowCut sphincterotome devices, immediate action is required to ensure patient safety. Read on for full details and steps to protect your patients and staff.
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## Why This Recall Is Important
Faulty medical devices can pose significant risks, particularly in clinical and surgical settings where precision is paramount. This recall is crucial because:
- **Potential Deformation**: Devices that did not undergo the proper thermoforming manufacturing process may deform, increasing the risk of failure during use.
- **Compromised Performance**: Affected products may not perform as intended, potentially leading to unsuccessful procedures or harm to patients.
- **Patient Safety at Risk**: The precise functionality of tools like sphincterotomes is essential to performing certain procedures without complications.
By addressing this issue immediately, Olympus aims to prevent adverse events and ensure healthcare settings are equipped with reliable tools.
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### Details of the Recall
The recall specifically targets **Disposable Triple Lumen Sphincterotome** and **Sphincterotome** devices manufactured by Olympus, under the CleverCut and FlowCut brand lines. The issue stems from certain lots that may not have undergone the necessary thermoforming manufacturing process.
Key facts include:
- **Manufacturer**: Olympus
- **Issue**: Devices potentially skipped thermoforming during production, leading to deformations and compromised operation.
- **Products Affected**: CleverCut and FlowCut sphincterotome devices, including the Disposable Triple Lumen Sphincterotome and Sphincterotome.
- **Action**: Users must stop using affected products immediately and contact Olympus’ customer service to return defective items.
- **Date Published**: [Refer to Official Source](https://recalls-rappels.canada.ca/en/alert-recall/clevercut-and-flowcut-sphincterotomes)
Healthcare providers should act quickly to review all stock and identify the affected lots.
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### What You Should Do
If you are a user or distributor of CleverCut and FlowCut sphincterotome devices, follow these steps immediately:
1. **Stop Usage**: Discontinue use of any CleverCut or FlowCut sphincterotome product.
2. **Check Inventory**: Review stock to determine if your products are part of the affected lots.
3. **Contact Olympus Customer Service**: Reach out to Olympus for guidance on returning defective devices.
4. **Replace Affected Products**: Ensure all defective items are replaced with devices that meet manufacturing standards to avoid service interruptions.
5. **Review Procedures**: Confirm that no patients were impacted by faulty devices, and document any adverse events if applicable.
Acting swiftly is essential to protect patient safety and maintain procedural reliability.
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### Stay Safe – Get Instant Recall Alerts
Healthcare institutions and consumers alike can stay updated on the latest recall information by subscribing to official notifications and utilizing technology for monitoring product safety:
- Download consumer safety apps to receive recall alerts directly to your phone.
- Visit the official Recall Canada Database [here](https://recalls-rappels.canada.ca/en/alert-recall/clevercut-and-flowcut-sphincterotomes) to stay informed about this and other recalls.
Keeping up with recalls is crucial to ensuring the health and well-being of your patients and staying compliant with safety standards.
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Olympus’ recall of the CleverCut and FlowCut sphincterotome devices underscores the importance of quality control in medical manufacturing. By taking immediate action, healthcare providers can protect their patients and maintain confidence in essential tools.
**CTA**: Protect your patients and stay informed! Download a reliable recall monitoring app today to get instant notifications about product recalls. Ensure you’re always one step ahead when it comes to safety.