CORE M2 Vascular System 400-0100.17Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00845225012663), received between Aug 10, 2021 and Mar 11, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT A CORE M2 SYSTEM WAS USED IN A PROCEDURE. DURING USE, THE SYSTEM FAILED TO RECOGNIZE THE IVUS PIM AND AN ERROR MESSAGE WAS DISPLAYED ON THE MONITOR. THE PROCEDURE WAS ABORTED AND WILL BE RESCHEDULED AT A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CORE M2 SYSTEM COULD NOT BE USED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576497 ↗
• MalfunctionJan 7, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT A CORE M2 SYSTEM WAS USED IN AN PROCEDURE. DURING USE, AN ERROR MESSAGE WAS DISPLAYED ON THE MONITOR. THE SYSTEM WAS REBOOTED THREE TIMES WITHOUT SUCCESS. THE CASE WAS ABORTED AND RESCHEDULED FOR A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE CORE M2 SYSTEM COULD NOT BE USED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096974 ↗
• MalfunctionOct 1, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE CORE M2 TOUCHSCREEN MONITOR WAS CRACKED. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK, RESULTING IN SHARP EDGES. THIS PRODUCT PROBLEM IS BEING REPORTED IN AN ABUNDANCE OF CAUTION BECAUSE THE TOUCHSCREEN MONITOR HAS SHARP EDGES THAT CAN RESULT IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20349407 ↗
• MalfunctionSep 26, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE CORE M2 VASCULAR SYSTEM TOUCHSCREEN MONITOR IS CRACKED WITH SHARP EDGES OBSERVED. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED IN AN ABUNDANCE OF CAUTION BECAUSE THE TOUCHSCREEN MONITOR HAS SHARP EDGES THAT CAN RESULT IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821842 ↗
• MalfunctionApr 12, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE CORE M2 SYSTEM TOUCHSCREEN MONITOR IS CRACKED WITH SHARP EDGES OBSERVED. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED IN AN ABUNDANCE OF CAUTION BECAUSE THE TOUCHSCREEN MONITOR HAS SHARP EDGES THAT CAN RESULT IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16727447 ↗
• MalfunctionAug 10, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE MANUFACTURER'S SYSTEM'S TOUCH PANEL GLASS IS CHIPPED AND BEGINNING TO FEEL SHARP TO THE CUSTOMER. NO USER INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE TOUCH PANEL DISPLAY HAS A SHARP EDGE THAT CAN RESULT IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304895 ↗