Pressure monitoring set recalled for potential pressure tubing detachment
Edwards Lifesciences is recalling the TruWave 3 cc/VAMP Jr pressure monitoring set (Lot #63598812) due to a potential risk that the pressure tubing may detach from the blood sampling system.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is described as a potential risk of equipment detachment without documented harm, meeting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC is recalling the Edwards TruWave 3 cc/VAMP Jr Kit (REF: VMP426PX), a pressure monitoring set used in medical settings. The affected lot is #63598812, with 50 units distributed in this recall.
The pressure tubing in this monitoring set may detach from the blood sampling system, potentially affecting its function. This is classified as an FDA Class II recall.
The product has been distributed throughout the United States (including Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia), as well as Puerto Rico. International distribution includes Canada, United Kingdom, and Italy.
The recalled product
- Product
- Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 50
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)
- Lot # 63598812
Distribution
Part of a larger recall action
This product is one of 8 recalled by Edwards Lifesciences, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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