The Recall Desk
HighFDA (Devices)·Z-2593-2014·Announced 2014-10-01

CareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk

CareFusion is recalling 1,729 EnVe and ReVel ventilators because operator misconnection can damage the power connector, potentially shorting the power adapter.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a risk of electrical shorting due to a mechanical defect. While no injuries are reported, the potential for electrical hazards in a life-support device places this in the 'High' category (risk-of-harm products where injury has not yet been reported).

Plain-English summary

CareFusion 203, Inc. is recalling 1,729 units of the EnVe and ReVel ventilators. These devices are designed for patients requiring respiratory support or mechanical ventilation and are used in hospital, transport, and homecare settings. The recall was initiated because the company identified a potential for damage to the power connector due to misconnection by the operator.

The input port on these ventilators requires adapters to be correctly aligned to function properly. If the alignment is incorrect, the pins in the connector may bend. This bending can cause the PTV AC power adapter and/or the PTV Auto Lighter Power Cord to be shorted. The affected units were distributed nationwide, including in states such as Alabama, Arizona, California, and Texas.

Healthcare facilities and users should check their serial numbers against the list provided by the manufacturer to determine if their unit is affected. If a unit is included in the recall, it should be removed from service and returned to CareFusion for repair or replacement according to the company's instructions.

The recalled product

Product
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of cont
Manufacturer
CareFusion 203, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
1,729

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Related recalls

Same manufacturer · CareFusion 203, Inc.

See all →

Same hazard · electrical short

See all →