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Amplatzer Torqvue Delivery System, Amplatzer Torqvue Low Profile Delivery Sys...

# Major Recall Alert: Amplatzer Torqvue Delivery System, Amplatzer Torqvue Low Profile Delivery System Recalled Due to Manufacturing Anomaly

Abbott has issued a **voluntary recall** of specific **4F Amplatzer™ Torqvue™ LP Delivery Systems (TVLP)** and **4F Amplatzer™ Torqvue™ LP Catheters (TVLPC)** due to a manufacturing anomaly. This recall impacts certain lots and requests that all unused affected products be returned immediately. Importantly, Abbott has confirmed that other lots not included in this recall are safe and can continue to be used. To date, there have been no reports of patient harm associated with these devices.

If you use or distribute these products, it is critical to know the details of this recall. Keep reading for everything you need to know about the next steps to ensure patient safety and compliance.

Release Date: **March 17, 2025**
For images and further details, [click here](https://recalls-rappels.canada.ca/en/alert-recall/amplatzer-torqvue-delivery-system).

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## Why This Recall is Important

Healthcare devices like the **Amplatzer Torqvue Delivery System** are pivotal tools in critical medical procedures. A manufacturing anomaly in specific lots of these products has prompted a precautionary recall to eliminate any potential safety risks.

Although there have been **no reported patient harm cases** to date, Abbott’s proactive approach underscores its commitment to safety and quality assurance within the healthcare industry. Distributors, clinicians, and manufacturers should take prompt action to identify and return any affected inventory.

Key Recall Highlights:
- **Impacted Devices:**
- 4F Amplatzer™ Torqvue™ LP Delivery System (TVLP)
- 4F Amplatzer™ Torqvue™ LP Catheter (TVLPC)
- **Reason for Recall:** A manufacturing anomaly affecting certain lots.
- **Start Date:** March 17, 2025.
- **Consumer Safety Notice:** Unaffected lots can still be used, ensuring minimal disruption.

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## Details of the Recall

Abbott has narrowed the recall to specific lots of the following devices:

**Brand:** Amplatzer Torqvue™
**Products:**
- Amplatzer Torqvue Delivery System
- Amplatzer Torqvue Low Profile Delivery System

### Important Facts to Note:
- **Reason for Recall:** A manufacturing issue that may impact device performance.
- **Action Required:** Users and distributors are advised to return all unused affected lots to Abbott for replacement or refund.
- **No Patient Harm Reported:** Abbott has confirmed no injuries or adverse events related to the recall.
- **Devices Not Affected:** All other lots outside the recall are safe for continued use.

For official details, visit the [Health Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/amplatzer-torqvue-delivery-system).

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## What You Should Do

If you use or distribute these medical devices, here are the steps you must take:

### For Healthcare Providers and Institutions:
- **Inspect Your Inventory:** Identify whether you have any of the impacted lots.
- **Return Affected Devices:** Send back any recalled products to Abbott immediately.
- **Continue Using Remaining Supplies:** Unaffected lots are confirmed safe for use.

### For Patients:
- If you have questions or concerns about a procedure involving these devices, contact your healthcare provider for clarity and reassurance.

Questions about the recall? Reach out to Abbott or consult your regional regulatory authority for further assistance.

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## Stay Safe – Get Instant Recall Alerts

Recalls can directly impact patient safety and should be acted upon immediately. Protect yourself, your patients, and your practice by staying up to date on safety announcements.

**Download the MyRecalls App** today to receive **real-time product recalls** straight to your device. Be proactive and always stay informed about the products you use daily!

![Amplatzer Torqvue Recall Products](https://myrecalls.app/images/products/28383_1743016843.jpg)

Stay ahead of recalls and safety updates – [click here](https://recalls-rappels.canada.ca/en/alert-recall/amplatzer-torqvue-delivery-system) to learn more about the Amplatzer Torqvue recall.

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**CTA:** Don’t take chances with medical safety. **[Download the MyRecalls App](https://myrecalls.app)** today and act quickly on key recall alerts!

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