Edwards Lifesciences Recalls Pressure Monitoring Sets with VAMP Plus System
Edwards Lifesciences is recalling Pressure Monitoring sets with VAMP Plus closed blood sampling systems due to incorrect assembly that may dilute blood samples.
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 hazard involves incorrect assembly leading to sample dilution, which is a quality issue without reported injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Edwards Lifesciences, LLC is recalling Pressure Monitoring sets with VAMP Plus closed blood sampling systems. The affected models include T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, and VP2. These devices are used on patients requiring periodic withdrawal of blood samples.
The recall was initiated because the firm received multiple complaints related to incorrect assembly, which may result in the dilution of blood samples. The agency classified this as a Class II recall. The source text does not report any specific illnesses or injuries associated with this defect.
Approximately 30,467 units were distributed nationwide in the United States and in Europe. Healthcare facilities and consumers should contact Edwards Lifesciences for instructions on how to handle the affected devices.
The recalled product
- Product
- Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system used on patients requiring periodic withdrawal of blood…
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Blood Sampling
- Affected units
- 30,467
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)
- 59184554
- 59187809
- 59191725
- 59221801
- 59227844
- 59238613
- 59326333
- 59356987
- 59401041
- 59222349
- 59227178
- 59234808
- 59284693
- 59328047
- 59270408
- 59284617
- 59276238
- 59401734
- 59270380
- 59319038
Distribution
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