ACUMEN IQ SENSOR AIQS6AZ5Recalls & reported problems
Edwards Lifesciences LLC · ACUMEN IQ SENSOR W/ VAMP ADULT 60"/152cm 5-Pack · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103200980), received between Mar 13, 2025 and Mar 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
3 other recalls cover devices cleared under the same FDA submission (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.
Reports received per month
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-0410-2024 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE TIP OF AN ACUMEN SENSOR WAS SEVERED AND DAMAGED DURING SET UP. ISSUE OCCURRED BEFORE CONNECTING TO PATIENT. NO ALLEGATIONS OF PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21595001 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under 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-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.
- Z-0411-2024 · Oct 4, 2023 · Open, ClassifiedFloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Other Transducer, Blood-Pressure, Extravascular devices
- Acumen IQ AIQS85Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall7 reports
- Acumen IQ AIQS8Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall1 report
- Acumen IQ AIQS8R5Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall1 report
- Acumen IQ AIQS65Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall0 reports
- NAMIC 70036160Medline Industries, Inc. · Transducer, blood-pressure, extravascular1 recall0 reports
- Acumen IQ AIQS6REdwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall0 reports
- NAMIC 64037107Medline Industries, Inc. · Transducer, blood-pressure, extravascular1 recall0 reports
- Acumen IQ AIQS6R5Edwards Lifesciences LLC · Transducer, Blood-Pressure, Extravascular1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.