ACUMEN IQ SENSORRecalls & reported problems across all models
Edwards Lifesciences LLC · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one ACUMEN IQ SENSOR model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of ACUMEN IQ SENSOR by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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 at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ACUMEN IQ SENSOR recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 4, 2023Class IIOpen, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported ACUMEN IQ SENSOR problems
Device problems
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
ACUMEN IQ SENSOR models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACUMEN IQ SENSOR AIQS6AZ5Transducer, Blood-Pressure, Extravascular1 recall1 report
- ACUMEN IQ SENSOR AIQS6AZTransducer, Blood-Pressure, Extravascular1 recall0 reports
Recent ACUMEN IQ SENSOR adverse event reports
The 1 most recent reports across all models, 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 ↗
Other Edwards Lifesciences LLC products
- Edwards SAPIEN 315 models · 6,905 reports · 1 recall
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
- INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
- EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
- SAPIEN 3 Ultra RESILIA4 models · 881 reports
- SAPIEN 3 Ultra System3 models · 876 reports
- FOGARTY32 models · 486 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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