IntraSight Mobile System 797415Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00845225012915), received between Feb 24, 2022 and Sep 18, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (51 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 24, 2022Open, Classified

   Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary control units, used as part of Mobile IVUS systems, are missing the following labeling information: Unique Device Identifier, Legal Manufacturer Information, Part Number, Rx Symbol, and Model Reference Information.

   Z-0901-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Poor Quality Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50824671 ↗
• MalfunctionJun 18, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR WAS CRACKED IN THE CORNER WITH SHARP EDGES. 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 25549538 ↗
• MalfunctionMay 1, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR HAD MULTIPLE CRACKS AND THE BRACKET WAS BENT. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 25061457 ↗
• MalfunctionMay 1, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM 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 WITH MISSING SCREEN MATERIAL, 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 25060902 ↗
• MalfunctionApr 30, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR SCREEN WAS CRACKED. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 25051634 ↗
• MalfunctionApr 22, 2026No Device Output

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM WAS TO BE USED FOR A STENT PLACEMENT PROCEDURE. HOWEVER, DURING USE, THE SYSTEM WAS UNABLE TO RECOGNIZE THE IVUS-PIM AND DISPLAYED A "CONNECT PIM" ERROR, EVEN WHEN CONNECTED. THE PROCEDURE WAS STOPPED SINCE IVUS WAS NEEDED FOR PROPER STENT SIZING, AND RESCHEDULED FOR A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE 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 24956701 ↗
• MalfunctionApr 7, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR WAS BROKEN. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24808701 ↗
• MalfunctionApr 3, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR WAS FOUND CRACKED ON THE CORNER, DURING DAILY INSPECTION. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24783163 ↗
• MalfunctionMar 20, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR WAS BROKEN. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24656212 ↗
• MalfunctionMar 13, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR WAS BROKEN AND CRACKED. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24597345 ↗
• MalfunctionMar 13, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR FELL AFTER EQUIPMENT RELOCATION AND BROKE THE SCREEN. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24594181 ↗
• MalfunctionMar 13, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR WAS DEFECTIVE/MECHANICALLY DAMAGED. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24591484 ↗
• MalfunctionMar 5, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM 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 WITH MISSING SCREEN MATERIAL, 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 24521831 ↗
• MalfunctionMar 5, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE 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 WITH MISSING SCREEN MATERIAL, 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 24521676 ↗
• MalfunctionMar 5, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE 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 WITH MISSING SCREEN MATERIAL, 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 24521521 ↗
• MalfunctionMar 5, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE 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 WITH MISSING SCREEN MATERIAL, 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 24521441 ↗
• MalfunctionMar 5, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE 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 WITH MISSING SCREEN MATERIAL, 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 24521359 ↗
• MalfunctionMar 5, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE 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 WITH MISSING SCREEN MATERIAL, 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 24521260 ↗
• MalfunctionFeb 18, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT MOBILE SYSTEM 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 WITH MISSING SCREEN MATERIAL, 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 24379882 ↗
• MalfunctionFeb 18, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT MOBILE SYSTEM 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 WITH MISSING SCREEN MATERIAL, 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 24379863 ↗
• MalfunctionFeb 17, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR (TSM) FELL DUE TO UNSECURED CLAMP, AND CRACKED THE SCREEN BUT STILL FULLY FUNCTIONAL. ADDITIONALLY, THE TSM BRACKET WAS FOUND BENT. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24372757 ↗
• MalfunctionFeb 17, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR WAS CRACKED BUT STILL FUNCTIONAL. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24372756 ↗
• MalfunctionFeb 5, 2026Computer Operating System Problem

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM WAS USED IN A PROCEDURE. DURING USE, THE SYSTEM ENCOUNTERED A MODALITY ERROR. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE PROCEDURE HAS TO BE RESCHEDULED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273817 ↗
• MalfunctionFeb 4, 2026Loss of Data

  IT WAS REPORTED THAT AN INTRASIGHT MOBILE SYSTEM WAS USED IN A PROCEDURE. DURING USE, THE SYSTEM TIMED OUT AND THE SCREEN WENT BLANK. THE PATIENT INFORMATION WAS LOST AND HAD TO STOP THE PROCEDURE. THE PATIENT WAS REMOVED FROM THE TABLE, AND THE PROCEDURE WAS RESCHEDULED FOR A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE PROCEDURE HAS TO BE RESCHEDULED; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261029 ↗
• MalfunctionFeb 3, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT MOBILE SYSTEM TOUCHSCREEN MONITOR GOT DAMAGED (CRACKED) WHEN BEING CLEANED AT THE CUSTOMER SITE. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, 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 24251157 ↗