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Therapy™ IBI-83366Recalls & reported problems

Irvine Biomedical, Inc. · Ablation Catheter · Class 3

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05414734306935), received between Jul 2, 2019 and Mar 24, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Impedance Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P040014); 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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Impedance Problem1

Patient problems

  • Cardiac Perforation1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 24, 2022Impedance Problem; Impedance Problem

    MANUFACTURER REF# 2030404-2022-00022. DURING AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA ABLATION, THE FIRST ABLATION CATHETER WAS SHAPED AND MANEUVERED IN THE TARGET ZONE AND THE IMPEDANCE WAS OVER 200 OHMS. AFTER RAISING THE IMPEDANCE LIMIT OF THE GENERATOR, THERAPY WAS DELIVERED, HOWEVER, THE TACHYCARDIA WAS UNABLE TO BE TREATED. THE DEVICE WAS REPLACED, BUT THE ISSUE REMAINED AND RF THERAPY WAS ABANDONED. THE PROCEDURE WAS COMPLETED USING A THIRD CATHETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13873698 ↗
  • InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    RELATED MANUFACTURING REF: 3008452825-2019-00308. DURING AN INCESSANT ATRIAL TACHYCARDIA PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THREE NON-ABBOTT DIAGNOSTIC CATHETERS WERE PLACED IN THE CORONARY SINUS, HIS BUNDLE , AND THE RIGHT VENTRICLE. MAPPING WAS COMPLETED AND TRANSSEPTAL WAS GOING TO BE PERFORMED. DURING PREPARATION FOR TRANSSEPTAL THE PATIENT WENT INTO ATRIAL FIBRILLATION RESULTING IN HYPOTENSION. AN ICE CATHETER REVEALED FLUID IN THE PERICARDIUM. HEPARIN WAS REVERSED AND THE PROCEDURE WAS CANCELLED. THE PATIENT IS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

    Patient problems: Cardiac Perforation

    MAUDE report 8752378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P040014. One submission often covers many models, so check the product and lot details in each record.

  • Z-3256-2011 · Feb 10, 2011 · Terminated
    7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725, Description: 1304-7-25-L-TH. St Jude Medical Company A sterile, single use catheter with one 4mm ab
  • Z-3255-2011 · Feb 10, 2011 · Terminated
    7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724, Description: 1304-7-25-M-TH. St Jude Medical Company A sterile, single use catheter with one 4mm a
  • Z-3257-2011 · Feb 10, 2011 · Terminated
    7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St Jude Medical Company A sterile, single use catheter with one 4mm a

Other Cardiac ablation percutaneous catheter devices

All Cardiac ablation percutaneous catheter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.