Edwards Lifesciences Recalls Vent Catheters Due to Stylet Coating Disruption
Edwards Lifesciences is recalling Vent Catheters because the white plastic coating on the stylet may disrupt. The action covers 157,305 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a potential defect (coating disruption) but does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Edwards Lifesciences, LLC is conducting a field action on its Vent Catheters. The recall is due to the potential for disruption of the white plastic coating on the stylet. The affected devices are packaged sterile and non-pyrogenic in a sealed, peel-type pouch and are intended for venting the left heart or left ventricle during short-term cardiopulmonary bypass.
The recall involves 157,305 units of the product. The affected model numbers are E061, E060, PE062, and EM012. Specific lot numbers are listed in the structured product information. The devices were distributed worldwide, including to the United States, Puerto Rico, and various international locations such as Australia, Canada, China, and Japan.
Healthcare providers and facilities should check their inventory for the affected model numbers and lot numbers. If the devices are found, they should be removed from use and returned to Edwards Lifesciences, LLC in accordance with the field action instructions.
The recalled product
- Product
- Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-term ( d 6 hrs) cardiopulmonary bypass. Avoid direct…
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 157,305
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 (20)
- Lots: 59134589
- 59346136
- 59499481
- 59609044
- 59717943
- 59138591
- 59192007
- 59149674
- 59350916
- 59514123
- 59620244
- 59723313
- 59138592
- 59199148
- 59202405
- 59370449
- 59528372
- 59625386
- 59723318
- 59148881
Distribution
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