Inquiry™ IBI-81871Recalls & reported problems
Irvine Biomedical, Inc. · Class 2
All models of Inquiry (31)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734306034), received between Oct 15, 2021 and Oct 15, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Activation, Positioning or Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
MANUFACTURER REPORT NUMBER: 3008452825-2021-00489. DURING AN SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS NOT DEFLECTING AS EXPECTED. THE CATHETER WAS EXCHANGED BUT THIS ISSUE PERSISTED WITH THE SECOND CATHETER. THE CATHETER WAS REPLACED WITH A THIRD CATHETER FROM A DIFFERENT BATCH AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. A PROCEDURE DELAY OCCURRED DUE TO THESE ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12638753 ↗MalfunctionOct 15, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
MANUFACTURER REPORT NUMBER: 3008452825-2021-00490. DURING AN SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS NOT DEFLECTING AS EXPECTED. THE CATHETER WAS EXCHANGED BUT THIS ISSUE PERSISTED WITH THE SECOND CATHETER. THE CATHETER WAS REPLACED WITH A THIRD CATHETER FROM A DIFFERENT BATCH AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. A PROCEDURE DELAY OCCURRED DUE TO THESE ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12638746 ↗
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- Inquiry™ IBI-81104Irvine Biomedical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 recall2 deaths64 reports
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- ACHIEVE ADVANCE™ 2ACH20Medtronic, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 deaths69 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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