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Infinity™ 5 Implantable Pulse Generator, Infinity™ 7 Implantable Pulse Genera...

# Major Recall Alert: Infinity™ 5, Infinity™ 7, Proclaim™ 5, Proclaim™ 7, Proclaim™ DRG, Proclaim™ XR 5, and Proclaim™ XR 7 Implantable Pulse Generators Recalled

Abbott has issued critical updates on their Infinity™ Deep Brain Stimulation (DBS) Neurostimulation System, Proclaim™ Spinal Cord Stimulation (SCS), and Proclaim™ Dorsal Root Ganglion (DRG) Neurostimulation Systems. The company is reminding healthcare providers about the "Surgery Mode" feature, designed to protect implanted devices from potential interference caused by electrosurgical units (ESUs) during surgical procedures. This recall aims to improve patient safety and ensure proper device usage.

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## Why This Recall is Important

Medical implant recalls are always a cause for concern, particularly when connected to devices that affect neurological or spinal health. Abbott's implantable pulse generators are highly sophisticated tools that help manage chronic pain and neurological conditions. Without proper activation of the Surgery Mode feature, patients may face risks of device interference, malfunction, or potential injury during surgeries involving ESUs.

This recall emphasizes the importance of safety communication between healthcare providers and patients with implanted devices. Inaccurate or incomplete use of Surgery Mode could expose patients to unnecessary harm, making this reminder essential for optimal device performance and overall safety.

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## Details of the Recall

Abbott’s notification affects a range of implantable pulse generators within their Infinity™ DBS, Proclaim™ SCS, and Proclaim™ DRG systems:

- **Affected Brands and Models**:
- Infinity™ 5 Implantable Pulse Generator
- Infinity™ 7 Implantable Pulse Generator
- Proclaim™ 5 Implantable Pulse Generator
- Proclaim™ 7 Implantable Pulse Generator
- Proclaim™ DRG Implantable Pulse Generator
- Proclaim™ XR 5 Implantable Pulse Generator
- Proclaim™ XR 7 Implantable Pulse Generator

- **Issue**: Devices must have the Surgery Mode feature enabled before procedures involving electrosurgical equipment. Failure to do so could lead to disruptions or problems with device function.

- **Safety Focus**:
- Protects the implanted device from ESU interference.
- Minimizes risks of patient injury during surgery.

- **Date Announced**: 32042

To view the official recall notice, visit the [Government of Canada Recall Page](https://recalls-rappels.canada.ca/en/alert-recall/abbott-s-proclaimtm-scsproclaimtm-drginfinitytm-dbs-implantable-pulse-generators).

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## What You Should Do

If you are a healthcare provider or patient using one of these devices, here are the steps to take:

1. **For Healthcare Providers**:
- Familiarize yourself with the device’s Surgery Mode feature.
- Ensure Surgery Mode is appropriately activated during procedures involving ESUs.
- Consult Abbott’s official resources or product guides for further clarification.

2. **For Patients**:
- If you have an affected pulse generator implant, discuss this recall with your healthcare provider immediately.
- Confirm whether Surgery Mode is enabled during any future medical procedures.
- Mention your device to all surgical teams to prevent misunderstandings.

Taking action now can help mitigate risks and ensure your safety.

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## Stay Safe – Get Instant Recall Alerts

Product recalls like this serve as crucial reminders of the importance of regular device communication and safety updates. Stay informed about vital recalls and safety notifications by downloading the official **Recalls and Safety Alerts** app. This app provides real-time updates and guidance directly to your smartphone, keeping you ahead of potential risks.

**Protect your health and safety—download the Recalls and Safety Alerts app today to stay informed!**

For more information on this recall and others, visit the [official recall notice on the Government of Canada’s website](https://recalls-rappels.canada.ca/en/alert-recall/abbott-s-proclaimtm-scsproclaimtm-drginfinitytm-dbs-implantable-pulse-generators). Stay vigilant, take action, and ensure peace of mind with your health devices.

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