FloTrac Sensor Recalled Due to Potential Flushing Difficulties During Setup
Edwards Lifesciences is recalling 1417 FloTrac Sensors used for intravascular pressure monitoring due to potential flushing difficulties during kit setup. No illnesses or injuries have been reported.
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 no reported illnesses or injuries. The hazard is theoretical—potential flushing difficulties during setup—so per the rubric, the maximum score for risk-of-harm products without reported injury is 3.
Plain-English summary
Edwards Lifesciences is recalling FloTrac Sensors (models MHD8, MHD85, MHD6R5, MHD8R, MHD8R5, and MHD8S) used for intravascular pressure monitoring. The recall was issued due to potential flushing difficulties that may occur during the setup of the pressure monitoring kit with the pressure transducer.
Approximately 1417 affected units were distributed across all 50 U.S. states and Puerto Rico, as well as to 30 countries including Canada, Europe, Australia, and Asia. Healthcare facilities and hospitals using these devices are affected by this recall.
The FDA has classified this as a Class II recall. Healthcare providers and facilities should contact Edwards Lifesciences for specific instructions regarding their affected devices and any recommended actions. No illnesses or injuries have been reported in connection with this issue.
For additional information about this recall, healthcare providers, patients, or caregivers should contact Edwards Lifesciences or consult the FDA website.
The recalled product
- Product
- FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
- setup-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 (11)
- MHD8: UDI: 00690103194609/ Lot # 64874824
- 64886991
- 64897466
- 64982736
- MHD85: UDI: 00690103194616/ Lot # 64858315
- MHD6R5: UDI:07460691949737/Lot # 65008717
- 65008718
- MHD8R: UDI: 07460691949829/Lot # 64892236
- 65009105
- MHD8R5: UDI:07460691949744/Lot # 64886927
- MHD8S: UDI: 07460691949805/Lot # 65048926
Distribution
Distributed in 51 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- HI
- IA
- ID
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- MT
- NC
- ND
- NE
- NH
- NJ
- NM
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
- WY
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