MHRA Flags Ventilator Failure Risk in Dräger Atlan Units

MHRA published a field safety notice on 4 August 2026 warning that Dräger Atlan A350 and A350XL anaesthesia workstations carry a risk of ventilator failure — the same manufacturing defect Dräger first corrected for US customers in October 2024, and which FDA classified as a Class I recall, its most serious category, a year later. The UK notice, DSI/2026/005, is the clearest signal yet of how far apart national vigilance timelines can run for the same device fault, even as no confirmed patient injuries have been reported anywhere it has surfaced.

What the notice says

DSI/2026/005 covers a manufacturing defect that can cause the piston ventilator in affected Atlan A350 and A350XL workstations to fail either before a case begins or mid-procedure. Because these are anaesthesia workstations, a ventilator failure during use means an immediate, unplanned transition to manual or spontaneous ventilation — not a gradual degradation an operator can plan around. MHRA's notice sets out the clinical consequences plainly: interrupted ventilation delivery that can cause hypoxia, loss of lung recruitment, bradycardia, cardiac arrest, and death if not managed promptly. The corrective action is a hardware fix — Dräger replacing the ventilator motor assembly — not a software update or a labeling change, which is why the remedy requires a service visit to every affected unit rather than a remote fix.

A defect with a long paper trail elsewhere

The UK notice is not the first regulatory action on this defect, and by a wide margin. Dräger sent an urgent medical device correction to all affected US customers on 15 October 2024. FDA subsequently classified the resulting recall as Class I — the agency's most serious designation, reserved for situations where continued use carries a reasonable probability of serious injury or death. Dräger expanded the scope of the correction in April 2026, identifying additional affected Atlan units beyond the original 2024 population, and Health Canada has separately posted its own recall notice covering the same devices. MHRA's field safety notice, dated 4 August 2026, is the first UK-specific public alert Regulatory News could identify for this defect — arriving roughly 22 months after the original US correction and four months after Dräger's own scope expansion.

What hospitals are told to do

• Know the manual mode: clinical staff should be familiar with the device's manual ventilation mode and their trust's protocol for a ventilation failure before using an affected unit.
• Continue use under supervision: while awaiting the hardware fix, affected devices can remain in use only with permanent supervision, per the instructions for use.
• Wait for the scheduled fix: Dräger will contact customers through local service representatives to arrange replacement of the ventilator motor assembly on affected units.
• No confirmed injuries to date: as of 29 July 2026, the manufacturer reports no confirmed patient injuries or deaths tied to the defect.