FDA Device recall Z-0412-2024
FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, 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 with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, 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-0412-2024 |
| 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 with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, 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 | MHD6AZ: UDI:00690103194722, Lot #: 64818047 64858313 64891437 64953982 MHD6AZ5: UDI: 00690103194746, Lot #: 64782419…MHD6AZ: UDI:00690103194722, Lot #: 64818047 64858313 64891437 64953982 MHD6AZ5: UDI: 00690103194746, Lot #: 64782419 64882668 64912054 64918246 64933574 64988043 65007223 65007224; MHD6C502: UDI: 00690103194760, Lot #: 64951410 |
|---|
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-0412-2024%22
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