FDA Device recall Z-0411-2024
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only
- FDA Device
- Class II
- ongoing
- Published 2023-12-06
On 2023-12-06 the FDA classified a Class II recall of FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only by Edwards Lifesciences, citing their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0411-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-04 |
| Published | 2023-12-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Edwards Lifesciences |
| Distribution | 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 |
Product
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Reason
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Identifiers
| code_info | MHD8: UDI: 00690103194609/ Lot # 64874824, 64886991, 64897466, 64982736; MHD85: UDI: 00690103194616/ Lot # 64858315; MH…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0411-2024%22
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