Moderate FDA (Devices)·Z-0413-2024·Announced 2023-12-06

TruWave Pressure Monitoring Set Recalled for Potential Flushing Difficulties

Edwards Lifesciences is recalling 118,570 units of the TruWave Pressure Monitoring Set due to potential flushing difficulties during setup. The device is used for hemodynamic pressure monitoring.

What this means for you

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: FDA Class II recall with no reported illnesses or injuries. The hazard is a potential setup difficulty rather than a confirmed safety event. Per the rubric, when no illnesses/injuries are reported and the hazard is theoretical, the score is at most 3. This procedural issue during device setup fits the Moderate category.

Plain-English summary

Edwards Lifesciences, LLC is recalling 118,570 units of the TruWave Pressure Monitoring Set. The recall affects multiple model configurations, including PX212, PX260, PX272, PX284, and numerous other variants, distributed throughout the United States and to 41 additional countries including Canada, Australia, United Kingdom, and Japan.

The recall is issued because of potential flushing difficulties that may occur during setup of the pressure monitoring kit with the pressure transducer. Flushing is a necessary step to prepare the device for use and ensure proper function.

The affected device is used in hospitals and clinical settings for hemodynamic pressure monitoring. Healthcare providers who have this device in use should contact Edwards Lifesciences for information and guidance. Facilities should verify their inventory against the specific model numbers and lot numbers listed in the recall notice.

The recalled product

Product: TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX600F (3cc), PXMK1876: x 3 (3 cc), PXMK1940: (3 cc), PXMK2024: (3cc)/77 in (196cm
Manufacturer: Edwards Lifesciences, LLC
Category: Medical Device — Hemodynamic Monitoring
Hazard: flushing-difficulty
setup-difficulty
Affected units: 118,570

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)

PX212: UDI: 07460691950221/Lot # 65087613
PX260: UDI: 07460691950191/Lot #64817892
64818036
64818038
64964776
64964780
64980121
65008760
65019888
65019889
65035079
PX2X2: UDI: 07460691950061/Lot # 64955114
65012789
65027868
65170585
PX3X3284C:UDI: 07460691950269/Lot # 64906878
65007202
65019845
PX4X4: UDI: 07460691950665/Lot # 64807960
64835551

Distribution

Distributed in 51 states:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · flushing difficulty