Agency classClass IOur severity:Severe FDA (Devices)·Z-1193-2019·Announced 2019-05-29

Edwards Lifesciences Recalls EV1000 Clinical Platform Due to Fire Hazard

Edwards Lifesciences is recalling EV1000 Clinical Platform monitors because liquid ingress into AC power outlets could cause an electrical short circuit and fire.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets."

Plain-English summary

Edwards Lifesciences, LLC is recalling the EV1000 Clinical Platform, including models EV1000A, EV1000NI, and EV1000CS. The EV1000A Monitor is used to optimize fluid management through minimally invasive monitoring with the FloTrac or Volume View sensor. The recall covers 22,443 units distributed worldwide, including nationwide in the United States and in numerous foreign countries.

The recall is due to a potential for an electrical short circuit leading to a possible fire hazard. This risk arises from liquid ingress into the AC power outlets of the devices. The source text does not report any specific injuries, illnesses, or fatalities associated with this defect.

Healthcare facilities and users of the EV1000 Clinical Platform should contact Edwards Lifesciences for instructions on how to proceed with the recall. The source text does not provide specific consumer action steps beyond the recall notification.

The recalled product

Product: EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Clinical Monitor
Hazard: fire
electrical-short
Affected units: 22,443

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All lots

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Same manufacturer · Edwards Lifesciences, LLC

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