Edwards Lifesciences Recalls ClearSight Heart Reference Sensor Due to Damage
Edwards Lifesciences is recalling ClearSight Heart Reference Sensors because the finger component may be damaged. The recall affects 1,309 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a potential mechanical defect in a medical device that measures vital signs, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC is recalling the ClearSight System, specifically the Heart Reference Sensor (Model No. EVHRS). The recall is being conducted because the finger component of the sensor may be damaged. The ClearSight system, used with the EV1000 Clinical Platform, noninvasively measures blood pressure and associated hemodynamic parameters.
A total of 1,309 units are affected by this recall, with 696 units distributed in the United States. The remaining units were distributed internationally to numerous countries, including Australia, Italy, Sweden, and the United Kingdom. The affected serial numbers range from 600104000221 to 600104005025.
Healthcare providers and consumers should stop using the affected ClearSight Heart Reference Sensors and contact Edwards Lifesciences for further instructions on how to proceed with the recall.
The recalled product
- Product
- ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
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 serial numbers. From 600104000221 to 600104005025
Distribution
Distributed nationwide across the United States.
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