InquiryRecalls & reported problems across all models
Irvine Biomedical, Inc. · 31 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 181
- Deaths reported
- 4
- Injuries reported
- 102
- Recalls
- 1
We found 31 models of Inquiry by Irvine Biomedical, Inc. in the FDA's device registry (GUDID). Together they are named in 181 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2018 and Feb 17, 2026 — classified as 4 deaths, 102 injuries, 75 malfunctions.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (14 reports).
1 FDA recall record name at least one of these models by its device identifier.
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
Inquiry 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.
- Aug 24, 2020Terminated
Steerable diagnostic catheter packages labeled Model IBI-81104, batch 7397352 incorrectly contained Model IBI-87002, batch 7397307. Packages labeled Model IBI-87002, batch 7397307 incorrectly contained Model IBI-81104, batch 7397352.If physicians fail to observe the catheter difference, the intracardiac electrograms will not be representative of the desired signals, could result in procedure delay
Z-3011-2020 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
Most reported Inquiry problems
Device problems
- Adverse Event Without Identified Device or Use Problem88
- Activation, Positioning or Separation Problem14
- Fracture14
- Difficult to Remove13
- Difficult to Insert9
- Component Misassembled8
- Material Deformation8
- Material Twisted/Bent7
Patient problems
- Cardiac Perforation78
- No Clinical Signs, Symptoms or Conditions47
- No Consequences Or Impact To Patient31
- Vascular Dissection6
- Foreign Body In Patient5
- Death4
- Stroke/CVA3
- Unspecified Tissue Injury3
Inquiry models
31 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Inquiry™ IBI-81104CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 recall2 deaths64 reports
- Inquiry™ IBI-81107CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING20 reports
- Inquiry™ IBI-81102CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING16 reports
- Inquiry™ IBI-81404CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING11 reports
- Inquiry™ IBI-81594CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING10 reports
- Inquiry™ IBI-81174CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death7 reports
- Inquiry™ IBI-81531CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING7 reports
- Inquiry™ D087023CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING7 reports
- Inquiry™ IBI-81172CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 reports
- Inquiry™ IBI-81659CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING4 reports
- Inquiry™ IBI-81105CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- Inquiry™ IBI-81402CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- Inquiry™ IBI-81530CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- Inquiry™ IBI-81683CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING3 reports
- Inquiry™ IBI-81403CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- Inquiry™ IBI-81871CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING2 reports
- Inquiry™ IBI-81144CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81202CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81207CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81418CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81473CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81521CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81532CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81680CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81734CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81918CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81938CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81945CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ IBI-81947CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 death1 report
- Inquiry™ IBI-87007CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
- Inquiry™ D087022CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING1 report
Recent Inquiry adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
AT THE BEGINNING OF THE PROCEDURE, WHILE PASSING THE CATHETER NEAR THE HIS BUNDLE, A BUNDLE BRANCH BLOCK WITH ASYSTOLE WAS TRIGGERED. STIMULATION WAS PERFORMED WITH THE NON-ABBOTT (EPTRACER BY SCHWARZER CARDIOTEK) UNTIL A TEMPORARY PACEMAKER WAS INSERTED. THE PATIENT REMAINS STABLE WITH PLANS TO PLACE A PERMANENT PACEMAKER. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE. THE CAUSE OF THE BLOCK WAS DUE TO A MANEUVER PERFORMED BY THE PHYSICIAN.
Patient problems: Heart Block
MAUDE report 24366853 ↗InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
DURING THE ATRIAL FIBRILLATION AND ATRIAL FLUTTER PROCEDURE WITH PULSED FIELD ABLATION, A PERICARDIAL EFFUSION WAS NOTED, RESULTING IN A PERICARDIOCENTESIS BEING PERFORMED. THE PROCEDURE WAS ABANDONED.
Patient problems: Cardiac Perforation
MAUDE report 24066869 ↗MalfunctionDec 17, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THE CURVATURE OF THE CATHETER WAS UNUSUAL RESULTING IN A DELAY. THE CATHETER WAS EXCHANGED HOWEVER THE SAME ISSUE OCCURRED WITH THE NEW CATHETER. THE CATHETER WAS EXCHANGED AGAIN TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23825054 ↗MalfunctionDec 17, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THE CURVATURE OF THE CATHETER WAS UNUSUAL RESULTING IN A DELAY. THE CATHETER WAS EXCHANGED HOWEVER THE SAME ISSUE OCCURRED WITH THE NEW CATHETER. THE CATHETER WAS EXCHANGED AGAIN TO RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23825053 ↗MalfunctionNov 10, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem
DURING THE SUPRAVENTRICULAR TACHYCARDIA RADIOFREQUENCY PROCEDURE, THERE WAS A DELAY. THE CATHETER COULD NOT BE INSERTED INTO THE PATIENT'S CORONARY SINUS. AFTER REMOVAL, IT WAS NOTED THAT THE TIP OF THE CATHETER WOULD NOT BEND. THE CATHETER WAS REPLACED AND THAT ISSUE WAS RESOLVED. IN ADDITION, THE SHEATH WAS BENT CLOCKWISE TO ALIGN WITH THE AXIS OF ROTATION. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511467 ↗MalfunctionSep 10, 2025Difficult to Insert; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Difficult to Insert; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem
DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, DIFFICULTY WITH POSITIONING THE CATHETER INTO THE CORONARY SINUS RESULTED IN A PROCEDURAL DELAY. THE CATHETER WAS SHAPED MANY TIMES; HOWEVER, IT WAS STILL NOT POSSIBLE TO MAKE THE CATHETER REACH THE APPROPRIATE POSITION. THE CATHETER WAS REPLACED BUT THE RESULT WAS THE SAME. BOTH CATHETERS COULD NOT GET TO THE DEEPER POSITION OF THE CORONARY SINUS AFTER LOSING BENDS. THE PROCESS LASTED ALMOST TWO HOURS. THE SECOND CATHETER WAS REPLACED WITH A NON-ABBOTT DEVICE (SYNAPTIC MEDICAL STEERABLE EP CATHETER) WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23020524 ↗MalfunctionSep 10, 2025Difficult to Insert; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Difficult to Insert; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem
DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, DIFFICULTY WITH POSITIONING THE CATHETER INTO THE CORONARY SINUS RESULTED IN A PROCEDURAL DELAY. THE CATHETER WAS SHAPED MANY TIMES; HOWEVER, IT WAS STILL NOT POSSIBLE TO MAKE THE CATHETER REACH THE APPROPRIATE POSITION. THE CATHETER WAS REPLACED BUT THE RESULT WAS THE SAME. BOTH CATHETERS COULD NOT GET TO THE DEEPER POSITION OF THE CORONARY SINUS AFTER LOSING BENDS. THE PROCESS LASTED ALMOST TWO HOURS. THE SECOND CATHETER WAS REPLACED WITH A NON-ABBOTT DEVICE (SYNAPTIC MEDICAL STEERABLE EP CATHETER) WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23020130 ↗MalfunctionSep 4, 2025Activation, Positioning or Separation Problem; Material Split, Cut or Torn; Activation, Positioning or Separation Problem; Material Split, Cut or Torn
THE REPORT IS TO ADVISE OF A CUT NOTED IN THE CATHETER DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22963592 ↗InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A HEART BLOCK OCCURRED REQUIRING PACING TO RESOLVE. DURING CATHETER PLACEMENT IN THE CORONARY SINUS THE AV NODE WAS BUMPED RESULTING IN TRANSIENT HEART BLOCK. THE HEART BLOCK REMAINED EVIDENT THROUGHOUT PROCEDURE AND RETURNED TO CCU WITH TEMPORARY PACING WIRE BACK UP. THERE ARE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PATIENT HAS BEEN DISCHARGED.
Patient problems: Heart Block
MAUDE report 22910187 ↗MalfunctionAug 11, 2025Use of Device Problem; Use of Device Problem
THIS REPORT IS TO ADVISE OF A CATHETER USED IN THE PATIENT PAST THE EXPIRATION DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22774590 ↗InjuryJun 18, 2025Difficult to Insert; Difficult to Insert
DURING A SUPRAVENTRICULAR TACHYCARDIA (SVT) ABLATION, A PERICARDIAL EFFUSION OCCURRED WITH NO INTERVENTION NEEDED. CARDIAC MOTION WAS RESTRICTED ON FLUOROSCOPY AND THE PATIENT EXPERIENCED MINOR CHEST PAIN. WHILE USING THE ICE CATHETER, AN EFFUSION WAS NOTED; TEE CONFIRMED A 0.5CM EFFUSION. NO INTERVENTION WAS REQUIRED; THE PROCEDURE WAS STOPPED AND THE PATIENT WAS OBSERVED OVERNIGHT. IT IS SUSPECTED THAT THE PERFORATION WAS DUE TO DIFFICULT RV PLACEMENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.
Patient problems: Cardiac Perforation
MAUDE report 22283747 ↗MalfunctionMay 19, 2025Fracture; Fracture
DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING THE CATHETER INTO THE PATIENT, DIFFICULTY WAS NOTED WHILE GAINING ACCESS INTO THE RIGHT ATRIUM. THE CATHETER WAS REMOVED FROM THE PATIENT AND A BEND/BREAK WAS NOTED. THE DISTAL TIP WAS FRACTURED BUT WAS STILL ATTACHED TO THE CATHETER. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043412 ↗MalfunctionApr 21, 2025Material Deformation; Material Deformation
DURING AN ATRIAL FIBRILLATION PROCEDURE, PIN 10 DID NOT DEFLECT AS EXPECTED AND APPEARED TO HAVE DIFFERENT SPACING. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21874118 ↗MalfunctionMar 25, 2025Signal Artifact/Noise; Signal Artifact/Noise
DURING A PREMATURE VENTRICULAR CONTRACTIONS (PVC) PROCEDURE IN THE RIGHT VENTRICLE (RV), NOISE ISSUES WITH THE EP CATHETER RESULTED IN A PROCEDURAL DELAY. THE CS CATHETER EGMS WERE NOISY AND THEN IMPROVED SOME. THE CS CATHETER WAS LEFT IN THE RA/SVC JUNCTION. MULTIPLE PVCS WERE OBSERVED SO THE MAPPING CATHETER WAS INSERTED INTO THE RIGHT ATRIUM (RA) TO PREPARE FOR MAPPING. EGMS ON THE MAPPING CATHETER WERE NOISY AS WELL. ALL CONNECTIONS WERE CHECKED. THE MAPPING CATHETER CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE CLARIS AND ENSITE WERE TURNED OFF AND ON AGAIN BUT THE NOISE ISSUE CONTINUED. ALL ECG CONNECTIONS WERE CHECKED AND THE RL AND RA PATCHES WERE REPLACED AND CHANGED TO CLARIS ECG ONLY BUT THE ISSUE WAS NOT RESOLVED. RETURNED TO ENSITE ECG AND REPLACED THE MAPPING CATHETER BUT STILL NO IMPROVEMENT. THE PHYSICIAN MOVED THE MAPPING CATHETER INTO THE RIGHT RV AND THE NOISE ISSUE WAS RESOLVED. AFTER ABLATION WAS COMPLETED, THE PHYSICIAN PULLED THE MAPPING CATHETER BACK INTO THE RA AND THE NOISE RETURNED. ON FLUOROSCOPY, THE MAPPING CATHETER WAS ADJACENT TO THE CS CATHETER SO IT IS THOUGHT THAT MAYBE THE NOISE ISSUE IS RELATED TO THE CS CATHETER. THE PROCEDURE WAS COMPLETED W
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21689331 ↗InjuryMar 21, 2025Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent
DURING THE ATRIAL FLUTTER PROCEDURE, WHILE PERFORMING THE SECOND ATTEMPT TO CORONARY SINUS CANNULATION USING NORMAL MANEUVERING, THE CATHETER BENT AND KINKED. A SNARE WAS USED TO REMOVE THE CATHETER THROUGH THE JUGULAR ACCESS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DEVICE WAS NOT STUCK ON ANOTHER DEVICE. THE PHYSICIAN THINKS THE KINK WAS CAUSED BY SIGNIFICANT TORQUE DURING MANEUVERING THE CATHETER.
Patient problems: Unspecified Vascular Problem
MAUDE report 21664026 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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