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U.S. Department of Health and Human Services

Medical Devices

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Esprit Ventilator

Class I Recall

Date Recall
Initiated:
June 8, 2001
Product:
ESPRIT Ventilator Model V1000
Use:
The device is a computer controlled, electrically powered, mechanical ventilator. It is intended to provide ventilatory support for adult and pediatric patients suffering breathing distress.
Recalling Firm:
Respironics California, Inc.
2271 Cosmos Ct.
Carlsbad, California 92009
Reason for Recall:
A material used to construct three check-valves in this ventilator predisposed them to premature failure. There have been two patient injuries resulting in partial or complete failure to permit ventilation.
Public Contact:
Kathy Moore
Director, Quality Assurance/Regulatory Affairs
760-918-7321
FDA District:
Los Angeles
FDA Comment:

There is a reasonable probability that use of the product presents a risk of serious adverse health consequences, including death.