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.
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: 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…
- Manufacturer
- Edwards Lifesciences, LLC
- 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
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.
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