Medtronic CareLink SmartSync Recalled for Software Error 2026: Health Canada

Health Canada has published a Type II recall for the Medtronic CareLink SmartSync Device Manager after a software calculation error was found to produce inaccurate Remaining Longevity estimates for certain Micra cardiac devices. The recall is listed under identification number RA-82715, with a recall date of September 24, 2026, and the notice was posted on October 1, 2026.

The notice is aimed at healthcare audiences. It covers three affected products tied to the CareLink and SmartSync system, and the affected lot and serial numbers are not listed in the public notice.

Recalled Products at a Glance

The recall involves three items made by Medtronic Inc. Each has more than ten lot or serial numbers, so Health Canada directs readers to the manufacturer for the full list.

• RF HEAD 24967 PATIENT CONNECTOR: model or catalogue number 24967
• CareLink SmartSync Device Manager App: model or catalogue number M01A02
• PROGRAMMER 24970A: model or catalogue number 24970A

Health Canada classifies the issue as ‘Medical devices – Performance’. The product falls under the general hospital and personal use and cardiovascular medical device categories.

What Triggered the Recall

The investigation began with a complaint received through the CareLink network. It reported a sudden drop in the Remaining Longevity of a patient’s Micra VR cardiac implantable electronic device (CIED), from 3 years to 6 months, following a remote transmission. That reading was later found to be incorrect.

Medtronic’s analysis found a calculation issue in SmartSync and CareLink affecting Micra VR2 and Micra AV2 devices. The problem occurs only under specific conditions, which the notice does not describe in further detail.

The cause is a software error. A function received an integer instead of a real data type. As a result, the average pacing rate defaulted to 60 beats per minute, which led to inaccurate Remaining Longevity estimates.

Why the Error Matters

Remaining Longevity is an estimate of how much operating life is left in an implanted device. Clinicians rely on figures like this when monitoring patients and planning follow-up care. An estimate that is too low or too high could distort that picture. In the reported complaint, the displayed longevity fell sharply from 3 years to 6 months, and that figure turned out to be wrong.

The public notice does not report any patient injuries. It also does not say how many units are affected or which lots are involved.

Who Should Be Concerned

The notice lists healthcare as the audience. Clinics, hospitals and cardiac device teams that use CareLink, SmartSync or the listed programmer and patient connector are the main groups concerned. Patients with Micra VR2 or Micra AV2 devices who are monitored through these systems may also want to ask their care team whether the notice applies to them.

Health Canada lists the issuing company as Medtronic Inc., located at 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States. The recall was published by Health Canada under its medical devices program.

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.

• Healthcare facilities should contact Medtronic Inc. for the full list of affected lot and serial numbers.
• Patients with a Micra VR2 or Micra AV2 device who have questions should speak with their cardiologist or device clinic.
• Patients should not make changes to their care on their own because of this notice.
• Anyone with a health or safety concern about a product can report it through Health Canada’s online reporting page.

Regulatory Response

Health Canada classified the action as a Type II recall and published it on its recalls and safety alerts portal. The notice carries identification number RA-82715. Health Canada’s page includes the manufacturer’s explanation of the software error and the list of affected products. It does not describe a software fix or a replacement schedule. Further details are available from the manufacturer.

Readers can subscribe to Health Canada’s email notifications to receive updates on new and revised recalls and safety alerts. The notice was last updated on October 1, 2026.

Quick Facts

• Company: Medtronic Inc.
• Recall number: RA-82715
• Recall class: Type II
• Recall date: September 24, 2026
• Published: October 1, 2026
• Issue: Software error causing inaccurate Remaining Longevity estimates
• Devices referenced: Micra VR2 and Micra AV2