Inquiry™ IBI-81532Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05414734304795), received between Jun 27, 2018 and Jun 27, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).
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
- Difficult or Delayed Positioning1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2018Difficult or Delayed Positioning; Difficult or Delayed Positioning
DURING AN ATRIAL TACHYCARDIA ABLATION PROCEDURE THE CATHETER BECAME ENTANGLED WITH AN INTRODUCER AND ADDITIONAL SURGERY WAS REQUIRED. FOLLOWING THE RIGHT FEMORAL PUNCTURE THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE DIAGNOSTIC CATHETER INTO THE PATIENT'S HEART DUE TO THE LOOP SHAPE OF THE CATHETER. RESISTANCE WAS FELT WHEN REMOVING THE CATHETER FOR REPOSITIONING. AN X-RAY WAS PERFORMED AND THE CATHETER WAS IN THE SHAPE OF AN 8 IN THE ILIAC AND FEMORAL VEIN. FOLLOWING FURTHER REPOSITIONING THE CATHETER BECAME ENTANGLED WITH THE INTRODUCER. THE INTRODUCER BROKE AND A FRAGMENT REMAINED WITHIN THE PATIENT. SURGERY WAS REQUIRED TO REMOVE THE CATHETER AND REMAINING FRAGMENT OF THE INTRODUCER FROM THE PATIENT. THE PATIENT WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7641299 ↗
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- Inquiry™ IBI-81104Irvine Biomedical, Inc. · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 recall2 deaths64 reports
- DECANAV R7F282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 deaths108 reports
- LASSO NAV D134301Biosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 deaths82 reports
- DECANAV R7D282CTBiosense Webster Inc · CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death75 reports
- 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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