The Recall Desk
HighFDA (Devices)·Z-1965-2021·Announced 2021-07-07

Pressure monitoring set recalled for potential pressure tubing detachment

Edwards Lifesciences is recalling the TruWave 3 cc/VAMP Jr pressure monitoring set (Lot #63598812) due to a potential risk that the pressure tubing may detach from the blood sampling system.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is described as a potential risk of equipment detachment without documented harm, meeting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Edwards Lifesciences, LLC is recalling the Edwards TruWave 3 cc/VAMP Jr Kit (REF: VMP426PX), a pressure monitoring set used in medical settings. The affected lot is #63598812, with 50 units distributed in this recall.

The pressure tubing in this monitoring set may detach from the blood sampling system, potentially affecting its function. This is classified as an FDA Class II recall.

The product has been distributed throughout the United 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, South Dakota, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia), as well as Puerto Rico. International distribution includes Canada, United Kingdom, and Italy.

The recalled product

Product
Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
Manufacturer
Edwards Lifesciences, LLC
Category
Medical Device — Pressure Monitoring Equipment
Hazard
  • tubing-detachment
  • pressure-system-failure

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 # 63598812

Distribution

Distributed in 33 states:

  • AZ
  • CA
  • CO
  • CT
  • DC
  • DE
  • FL
  • GA
  • ID
  • IL
  • IN
  • KY
  • LA
  • MA
  • MD
  • ME
  • MI
  • MN
  • MO
  • MS
  • MT
  • NC
  • ND
  • NE
  • NJ
  • PR
  • SD
  • TX
  • UT
  • VA
  • WA
  • WI
  • WV

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