FLOTRAC MHD85Recalls & reported problems
Edwards Lifesciences LLC · FLOTRAC SENSOR (84" / 213CM) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (K131588, K131892, K152980); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 4, 2023Open, Classified
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Z-0411-2024 · Root cause: Device Design · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131588, K131892, K152980. One submission often covers many models, so check the product and lot details in each record.
- Z-0412-2024 · Oct 4, 2023 · Open, ClassifiedFloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.
- Z-0410-2024 · Oct 4, 2023 · Open, ClassifiedAcumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
- Z-0409-2024 · Oct 4, 2023 · Open, ClassifiedAcumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Other CATHETER, OXIMETER, FIBEROPTIC devices
- HemoSphere HEM1Edwards Lifesciences LLC · Catheter, Oximeter, Fiberoptic1 recall65 reports
- HemoSphere HEMOXSC100Edwards Lifesciences LLC · Catheter, Oximeter, Fiberoptic1 recall11 reports
- HemoSphere HEMSGM10Edwards Lifesciences LLC · Catheter, Oximeter, Fiberoptic1 recall5 reports
- SWAN GANZ SGPT54Edwards Lifesciences LLC · Catheter, Oximeter, Fiber-Optic1 recall0 reports
- SWAN-GANZ SGPT755PEdwards Lifesciences LLC · Catheter, Oximeter, Fiber-Optic1 recall0 reports
- SWAN GANZ SGPT64PEdwards Lifesciences LLC · Catheter, Oximeter, Fiber-Optic1 recall0 reports
- HemoSphere Alta ALTAALL1Edwards Lifesciences LLC · Catheter, Oximeter, Fiber-Optic22 reports
- ICU Medical 41239-06Icu Medical, Inc. · Catheter, oximeter, fiber-optic19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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