Edwards TruWave Pressure Monitoring Set: Potential Tubing Detachment
Edwards Lifesciences is recalling a pressure monitoring set due to potential detachment of the pressure tubing from the blood sampling system. The recall affects 290 units distributed across multiple US states and international locations.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard represents a risk-of-harm product (potential tubing detachment in a critical monitoring device) where injury has not yet been reported, fitting the rubric definition for Score 3 (High).
Plain-English summary
Edwards Lifesciences, LLC is recalling the Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, a pressure monitoring set used in medical settings. The device is model T443952B.
The recall is due to a potential that the pressure tubing may detach from the blood sampling system. No illnesses or injuries have been reported in connection with this issue.
Approximately 290 units of lot number 63479666 were distributed across multiple US 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, Puerto Rico, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia, as well as Canada, the United Kingdom, and Italy.
Healthcare facilities and users of this device should contact Edwards Lifesciences for information regarding the recall and any recommended actions.
The recalled product
- Product
- Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
- Manufacturer
- Edwards Lifesciences, LLC
- Affected units
- 290
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 # 63479666- Not Marketed within the US
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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