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.
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 3/5 (High).
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
- Affected units
- 1,417
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
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
See all →- ModerateEdwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
FDA (Devices) · 2026-05-20
- SevereFEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI16 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
Same hazard · setup failure
See all →- HighAcumen IQ Sensor Intravascular Pressure Monitor Flushing Difficulty
FDA (Devices) · 2023-12-06
- HighEdwards TruWave pressure monitoring kit recalled for setup issues
FDA (Devices) · 2023-12-06
Similar recalls
- ModerateEdwards Lifesciences Recalls FloTrac Sensor Due to Packaging Error
FDA (Devices) · 2013-09-18
- ModerateEdwards Pressure Monitoring Kit Recalled for Flow Restriction Issues
FDA (Devices) · 2015-09-23
- HighEdwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage
FDA (Devices) · 2015-06-17
- ModerateIntegra Pudenz Flushing Valve Recalled for Incorrect Labeling
FDA (Devices) · 2012-07-18
- HighEdwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak
FDA (Devices) · 2018-05-30
- ModerateEdwards TruWave Pressure Monitoring Set Tubing Detachment Recall
FDA (Devices) · 2021-07-07