Bluetooth Disconnections Prompt Medtronic CareLink SmartSync Recall 2026

Health Canada has published a Type II health product recall, reference number RA-82784, covering the Medtronic CareLink SmartSync Device Manager and several associated components. The notice was posted on October 14, 2026, and lists a recall date of September 24, 2026. It is aimed at the healthcare audience rather than the general public.

The concern centres on Bluetooth connections. According to the notice, disconnections during a SmartSync patient session may lead to harm because of undesirable or incomplete parameter programming.

Recall at a Glance

• Product: CareLink SmartSync Device Manager
• Brand and company: Medtronic Inc.
• Recall class: Type II
• Issue: Medical devices – Performance
• Recall number: RA-82784
• Recall date: 2026-09-24
• Published by: Health Canada on 2026-10-14

Products Affected by This Recall

Health Canada lists three affected items. Each one has a long list of lot or serial numbers. The notice says there are more than 10 numbers for each and directs readers to the manufacturer for the full list.

• Patient Connector: model or catalogue number 24967
• CareLink SmartSync 24970A: model or catalogue number 24970A
• CareLink SmartSync Common Application: model or catalogue number M01A02

The notice classifies the products under two Health Canada medical device categories: Cardiovascular, and General hospital and personal use. The manufacturer is Medtronic Inc., located at 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States.

What Went Wrong?

The SmartSync device manager software runs on an Apple iPad and communicates over Bluetooth with its accessories. These are the SmartSync base station and the patient connector. Health Canada’s notice explains that Bluetooth disconnections can happen for a variety of reasons.

The recall addresses one specific cause: data corruption between the iPad’s Bluetooth controller and the SmartSync base station or patient connector. An update within the Apple iPad Operating System (iPadOS) may reduce those disconnections.

If a disconnection happens in the middle of a SmartSync patient session, the programming of device parameters may not complete as intended. The notice describes the resulting risk as harm due to undesirable or incomplete parameter programming. It does not report specific injuries or incidents, and it does not give a number of affected units.

Who Should Be Concerned

The notice lists its audience as Healthcare. That points to clinics, hospitals and other professional settings where the SmartSync device manager is used, along with the clinicians who work with the system. The recall page is published by Health Canada’s medical devices program, and the spatial coverage is listed as Canada.

Because the lot and serial numbers are not printed on the page, facilities cannot confirm whether a specific unit is included without checking with Medtronic. The three model and catalogue numbers above are the quickest starting point for an inventory check.

Steps Consumers Should Take

Health Canada’s guidance is brief. The what-to-do section says to contact the manufacturer if you require additional information. Based on the notice, healthcare users can take these practical steps:

• Check whether your facility uses the Patient Connector (24967), the CareLink SmartSync 24970A, or the CareLink SmartSync Common Application (M01A02).
• Contact Medtronic Inc. to obtain the full list of affected lot or serial numbers.
• Ask Medtronic about the Apple iPadOS update described in the notice and how it applies to your setup.
• Report any health or safety concern to Health Canada through its online reporting page.

The notice does not say whether devices must be returned, replaced or refunded. Any such details would come from the manufacturer.

Regulatory Response

Health Canada assigned the recall to Type II. The notice does not spell out the class definition, so this article does not characterize it beyond the label. The agency lists the issue as Medical devices – Performance and describes the action as a health product recall.

The recall page also offers email notifications for new and updated recalls and safety alerts. Healthcare organizations that rely on connected devices can subscribe to receive updates from Health Canada, which may help them catch later changes to this notice.

For now, the available information is limited to what Health Canada has published. Anyone who needs details on affected serial numbers, software versions or next steps should contact Medtronic directly and refer to recall number RA-82784.