Health Canada posts Class II recall of Maquet RotaFlow Console over battery charging fault
A software problem can stop the RotaFlow Console charging its battery after battery mode has been used, and the manufacturer treats all marketed devices as affected.
Health Canada has published a Class II recall of the RotaFlow Console, a cardiovascular medical device made by Maquet Cardiopulmonary GmbH of Rastatt, Germany. The recall date is 27 October 2026, and the notice was published on 29 October under identification number RA-82878.
According to the notice, the problem came to light during internal validation of new replacement batteries at the manufacturer, referred to as MCP. The testing showed that the console can stop charging its battery after the battery operation mode has been used.
Further investigation traced the fault to a software problem. For that reason, the notice states, all devices on the market are considered affected. The recall covers model or catalogue number 70104.3292, and the notice lists more than 10 serial or lot numbers, directing readers to the manufacturer for the full list.
The only action given in the notice is to contact the manufacturer for additional information. It does not describe a corrective software update, a timeline for a fix, or any reported patient harm. Under Health Canada's system, a Type II recall generally involves products that may cause temporary or medically reversible health effects, or where the likelihood of serious harm is remote.
What it means for your team
- Healthcare facilities using RotaFlow Consoles in Canada should contact Maquet Cardiopulmonary for the full list of affected serial numbers and further details.
- Because the manufacturer treats all marketed devices as affected, a software root cause suggests the issue is not confined to specific batches.
- Quality and regulatory teams should note that the notice gives no details on corrective actions or timelines, and watch for further updates from Health Canada or the manufacturer.
- Device-vigilance teams may wish to check whether similar battery-related issues have been recorded for the device in other markets, though the notice itself covers Canada only.
Official source: Health Canada ↗
Article written by VigiEye from the official source (Health Canada). AI-assisted; check the source before acting.
Market accessCompany releaseMedicare begins paying for Lucid's EsoGuard as PAVmed's Veris nears FDA 510(k) filing
Market accessOfficialDenmark updates Voltabak eye drop supply notice, with shortage expected to run to mid-May 2027
Market accessOfficialMethergin 0.2 mg/ml injection withdrawn from Danish market, DKMA reports
Market accessOfficialDenmark updates import window for estradiol 25 microgram patches in supply failure
Market accessOfficialDKMA updates Vivelle Dot 37.5 supply notice: shortage expected to last until end of December
Market accessOfficial