The Recall Desk
HighFDA (Devices)·Z-0414-2024·Announced 2023-12-06

Edwards TruWave pressure monitoring kit recalled for setup issues

Edwards Lifesciences is recalling 168,014 TruWave with Vamp pressure monitoring kits due to potential flushing difficulties during setup. The recall affects devices distributed across the US and internationally.

What this means for you

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 a Class II FDA recall for a potential functional defect in a critical care medical device. While no illnesses or injuries have been reported and the hazard is described as potential (theoretical), the risk of functional failure in pressure monitoring equipment without reported adverse events meets the criteria for High severity: a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Edwards Lifesciences, LLC is recalling the TruWave with Vamp System pressure monitoring set, which includes multiple reference numbers and configurations. The recall affects 168,014 units distributed across all U.S. states and international locations including Canada, Australia, Japan, and other countries.

The reason for the recall is the potential for flushing difficulties during the setup of the pressure monitoring kit with pressure transducer. This is classified as a Class II recall by the FDA.

Consumers and healthcare professionals using the affected pressure monitoring kits should contact Edwards Lifesciences for guidance on the recall. The company can provide instructions on proper setup or facilitate replacement of the affected units.

The recalled product

Product
TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc)/VAMP 68in (174cm); PXVMP2X21: x2 (3cc)/VAMP; PXVMP2X22: x2 (3cc)/VAMP 63 in
Manufacturer
Edwards Lifesciences, LLC
Category
Medical Device — Vascular Monitoring
Hazard
Affected units
168,014

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)

  • PXAVMP:UDI: 00690103011494/Lot # 64817849
  • PXAVMP3: UDI:07460691950085/Lot # 64918575
  • PXVK0364:UDI:07460691954526/Lot # 64858007
  • PXVK0853: UDI: 07460691957671/Lot # 65060361
  • PXVK0996:UDI: 07460691955431/Lot # 64858275
  • PXVMP2X21:UDI: 07460691950115/Lot # 64992080
  • PXVMP2X22: UDI: 00690103016765/Lot # 64891427
  • PXVMP3X32:UDI: 0690103016802/Lot # 65008748
  • PXVP0041: UDI: 00690103197983/Lot # 64835537
  • PXVP0550:UDI: 07460691949911/Lot # 64818013
  • 64858077
  • 64891424
  • 64918588
  • 64985484
  • PXVP1071: UDI: 07460691955462/Lot # 64807998
  • 64807999
  • PXVP1087: UDI: 07460691957886/Lot # 65035078
  • 65079515
  • PXVP2260: UDI: 07460691950108/Lot # 64858071
  • 64858103

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 →

Related recalls

Same manufacturer · Edwards Lifesciences, LLC

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Same hazard · flushing difficulty

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