iLab™ Polaris Multi-Modality Guidance System H74939322120C0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729946106), received between May 15, 2020 and Mar 3, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Computer Operating System 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2025Device Displays Incorrect Message; Connection Problem; Device Displays Incorrect Message; Connection Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. AN ILAB ULTRASOUND IMAGING SYSTEM WAS USED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE IVUS PROCEDURE, ON THE FIRST CONNECTION WHEN THE OPTICROSS WAS INSERTED, THE IVUS SYSTEM POLARIS WAS INDICATED AS A SIMULATOR, AND IT WAS UNABLE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509858 ↗
• MalfunctionAug 17, 2020No Display/Image; No Display/Image

  IT WAS REPORTED THAT A CANCELLED PROCEDURE OCCURRED. A POLARIS MMG SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE UNIT IS EXPERIENCING IMAGE ISSUES. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Complaint, Ill-Defined; No Consequences Or Impact To Patient

  MAUDE report 10417228 ↗
• MalfunctionJul 9, 2020Computer Operating System Problem; Computer Operating System Problem

  IT WAS REPORTED THAT A CANCELLED PROCEDURE OCCURRED. AN ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE IT WAS NOTED THAT THE UNIT IS NOT COMPLETING START UP AND NOT FINDING ACQ PC. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Complaint, Ill-Defined; No Consequences Or Impact To Patient

  MAUDE report 10252334 ↗
• MalfunctionMay 22, 2020Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT POLARIS CANNOT BOOT UP OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A POLARIS MMG SYSTEM WAS USED. DURING PREPARATION. THE TECHNICIAN WANTS TO START UP POLARIS BUT WAS UNABLE TO BOOT UP. THE SCREEN SHOWED NOTHING SO THEY DECIDED TO CANCEL/RESCHEDULE THE PROCEDURE. PATIENT WAS ALREADY SEDATED WHEN THE PROBLEM OCCURRED BUT PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10083296 ↗
• MalfunctionMay 15, 2020Failure to Power Up; Computer Operating System Problem; Failure to Power Up; Computer Operating System Problem

  IT WAS REPORTED THAT A CANCELLED PROCEDURE OCCURRED. A POLARIS MOBILE 120V WAS USED AS THE CONSOLE TO VIEW THE TARGET LESION. IT WAS NOTED THAT THE PATIENT WAS SEDATED. DURING PERCUTANEOUS CORONARY INTERVENTION, THE POLARIS SCREEN DISPLAYED STARTUP FAILURE AND ACQUISITION PC NOT POWERED ON. THEREFORE, THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10063088 ↗