CORE Mobile System Medical Equipment 400-0100.07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00845225012274), received between Oct 24, 2024 and Aug 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 reports).

10 other recalls cover devices cleared under the same FDA submission (K123898); 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT A CORE MOBILE SYSTEM WAS USED IN A PROCEDURE. DURING USE, PRESSURE MEASUREMENTS WERE NOT POSSIBLE. THE SYSTEM WAS UNPLUGGED AND REBOOTED, BUT COULD NOT BE RESOLVED. A BREAK WAS OBSERVED ON THE FFR PIMMETTE CABLE; THEREFORE, THE CABLE WAS REPLACED BUT DID NOT FULLY RESOLVE THE ISSUE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THE DEVICE WAS BEING USED IN AN EMERGENT PROCEDURE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED IN AN ABUNDANCE OF CAUTION BECAUSE IT IS UNKNOWN IF THE FAILURE OCCURRED DURING AN EMERGENT PROCEDURE; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795071 ↗
• MalfunctionNov 29, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A CORE MOBILE SYSTEM WAS USED IN A CORONARY DIAGNOSTIC EMERGENT PROCEDURE. DURING PREPARATION FOR USE, THE EQUIPMENT FUSE BURNED OUT AND THE SYSTEM SHUT DOWN. THE CASE WAS COMPLETED WITHOUT THE USE OF IVUS. NO INJURY TO PATIENT OR USER WAS REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE SYSTEM COULD NOT BE USED DURING AN EMERGENT CASE DUE TO A BURNT FUSE; RESULTING IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20811141 ↗
• MalfunctionOct 24, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT A CORE MOBILE SYSTEM WAS USED IN A CORONARY THERAPEUTIC PROCEDURE. DURING USE, THE EQUIPMENT FUSE BURNED OUT AND IVUS PROCEDURE WAS STOPPED. THE CASE WAS COMPLETED WITHOUT THE USE OF IVUS. NO INJURY TO PATIENT OR USER WAS REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CORE MOBILE FUSE WAS BURNT. THERE IS A POTENTIAL FOR HARM IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20529246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123898. One submission often covers many models, so check the product and lot details in each record.

• Z-0189-2018 · Nov 3, 2017 · Terminated
  Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) REF 400-0100.01; CORE Mobile Imaging System Refurbished REF 400-0100.01-R; CORE Mobile Imaging System (2
• Z-1813-2016 · Apr 25, 2016 · Terminated
  Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v3.4 software kits. Cardiology: The Volcano Universal (Core /Core Mobile), S5iz Platform Imaging System
• Z-2131-2015 · Jun 22, 2015 · Terminated
  Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The
• Z-2136-2015 · Jun 22, 2015 · Terminated
  Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Vo
• Z-2135-2015 · Jun 22, 2015 · Terminated
  Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: T
• Z-2132-2015 · Jun 22, 2015 · Terminated
  Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Vol
• Z-2134-2015 · Jun 22, 2015 · Terminated
  Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Vol
• Z-2133-2015 · Jun 22, 2015 · Terminated
  Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology:
• Z-2044-2015 · Sep 23, 2013 · Terminated
  Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - 807400-001; CORE - 400-0 I 00.02. Intravas
• Z-2043-2015 · Sep 23, 2013 · Terminated
  Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s5x - 807300-001; CORE MOBILE - 400-0100.01.