Edwards TruWave Pressure Monitoring Set Tubing Detachment Recall
Edwards Lifesciences is recalling Edwards TruWave pressure monitoring sets due to potential tubing detachment from the blood sampling system. No illnesses or injuries have been reported.
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: This FDA Class II recall involves a theoretical hazard—potential tubing detachment from a pressure monitoring system—with no reported illnesses, injuries, or deaths. Per the rubric, medical device defects classified as Class II with documented incidents absent fall into the Moderate category.
Plain-English summary
Edwards Lifesciences, LLC is recalling Edwards TruWave pressure monitoring sets (Model PXVJ0711). The recall affects 700 units that were distributed across multiple U.S. states and internationally to Canada, the United Kingdom, and Italy.
The recall is issued because the pressure tubing may detach from the blood sampling system. Affected lot numbers are 63470654, 63505217, and 63592430. If the tubing detaches during use, the pressure monitoring function may be compromised.
No illnesses or injuries have been reported in relation to this defect. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 07460691954489
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- Affected units
- 700
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 (2)
- Lot #s: 63470654
- 63505217 and 63592430
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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