Agency classClass IIOur severity:High FDA (Devices)·Z-1964-2021·Announced 2021-07-07

Edwards TruWave Pressure Monitoring Set Recalled for Potential Tubing Detachment

Edwards Lifesciences is recalling 990 units of the Edwards TruWave (30 cc)/VAMP Jr Kit pressure monitoring set because the pressure tubing may detach from the blood sampling system. Healthcare facilities should discontinue use.

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 medical device recall for a risk-of-harm product where patient monitoring capability could be lost if tubing detaches. No incidents or injuries have been reported to date.

Plain-English summary

Edwards Lifesciences, LLC is recalling 990 units of the Edwards TruWave (30 cc)/VAMP Jr Kit, Lot #63438489, a prescription pressure monitoring set used in healthcare settings.

The FDA identified a potential for the pressure tubing to detach from the blood sampling system during use. If detachment occurs, the pressure monitoring function would be lost, potentially compromising patient monitoring and care.

The affected units were distributed across the United States (Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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 using this product should immediately discontinue use and contact Edwards Lifesciences for replacement or further instructions.

The recalled product

Product: Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Pressure Monitoring System
Hazard: tubing-detachment
monitoring-system-failure
Affected units: 990

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 # 63438489

Distribution

Distributed in 33 states:

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.

See all 8 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · tubing detachment