Health Canada Recalls Cynosure DermaV Laser System Over Burn Risk

Health Canada has classified a Type II recall for the Cynosure DermaV laser system after the device’s manufacturer flagged a troubling pattern of complaints linked to patient burns. The recall, identified under reference number RA-82528, was dated August 6, 2026 and published by Health Canada’s medical devices program on August 26, 2026.

The affected device is the ‘DermaV’, model or catalogue number 1011600210, manufactured by Cynosure Lutronic Technology Corporation. No specific lot or serial numbers were listed for the affected units, as the issue applies broadly to the device model itself rather than a specific production batch.

What Went Wrong?

According to Health Canada, Cynosure Lutronic identified an adverse trend of complaint reports across North America describing sparking and loud noises occurring during vascular treatments performed with the DermaV system. In some of these incidents, the sparking event was followed by a burn to the patient being treated.

The company’s investigation traced the issue to a specific combination of settings. There is a remote possibility that using higher fluences at the 1064 nm wavelength, combined with the device’s current cryogen cooling parameters, can trigger a spark or loud noise during treatment. In rare cases, this event can result in a burn to the patient’s skin. The recall notice describes the risk as remote but confirms it has occurred with sufficient frequency across North America to prompt formal action.

Products Affected by This Recall

The recall applies specifically to the DermaV laser system bearing model number 1011600210. Health Canada’s affected products table lists no applicable lot or serial number range, meaning the concern is tied to the device design and its operating parameters rather than an isolated manufacturing defect.

The DermaV is used in clinical settings for vascular laser treatments, a category of procedures aimed at addressing visible blood vessels and related skin conditions using targeted laser energy.

Who Is Affected?

This is a health product recall aimed at a professional audience rather than the general public. Health Canada lists the intended audiences as healthcare providers and industry, meaning clinics, medical spas, dermatology practices, and other facilities operating the DermaV system are the primary parties expected to act on this notice.

Patients who have undergone vascular treatments with this device may also want to be aware of the reported burn risk, particularly if they experienced an unexpected spark, loud noise, or unusual skin reaction during or after a session.

Steps Consumers Should Take

Health Canada’s guidance for this recall is direct: facilities and practitioners using the DermaV laser system should contact the manufacturer, Cynosure Lutronic Technology Corporation, if they require additional information about the affected device or the fluence and cryogen settings involved.

Clinics operating the device should review their treatment protocols for vascular procedures at the 1064 nm wavelength and remain alert for any signs of sparking or unusual noise during use. Any adverse events, including burns linked to the DermaV system, should be reported to Health Canada through its established channels for health and safety concerns.

From the Agency

Health Canada’s notice states plainly that ‘Cynosure Lutronic has identified a adverse trend of complaint reports in North America for spark and loud noise resulting in patient burns during vascular treatment with the DermaV laser system.’ The agency further notes that there is ‘a remote possibility’ that higher fluences at the 1064 nm wavelength, combined with current cryogen parameters, can result in a spark or loud noise that could potentially cause a patient burn.

The recall is classified as Type II, one of Health Canada’s mid-tier severity classifications for medical device recalls, reflecting a situation that could cause temporary or medically reversible harm. The company, headquartered in Goyang-si, Gyeonggi-do, South Korea, is listed as the responsible party for follow-up with affected facilities.

Health Canada has not indicated a broader public recall or refund process, as this notice is directed at the healthcare and industry audiences who operate or purchase the equipment directly.