Edwards TruWave Pressure Monitoring Set Recalled Due to Tubing Detachment Risk
Edwards Lifesciences is recalling Edwards TruWave (3 cc)/VAMP Jr Pressure Monitoring Sets (Lot 63545959) due to a potential risk that 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 device with a potential equipment failure hazard (tubing detachment from blood sampling system). No reported illnesses or injuries, and the hazard is theoretical, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Edwards Lifesciences, LLC has recalled the Edwards TruWave (3 cc)/VAMP Jr Pressure Monitoring Set (Reference VMP406PX, Lot 63545959). This medical device is used in healthcare settings to monitor patient blood pressure.
The recall was initiated due to a potential risk that the pressure tubing may detach from the blood sampling system. Such a disconnection could compromise blood pressure monitoring during patient care.
Approximately 90 units were distributed across multiple U.S. states as well as to Canada, United Kingdom, and Italy.
Patients and healthcare providers who may have received this device should contact their healthcare facility or Edwards Lifesciences. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- tubing-detachment
- equipment-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 # 63545959
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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