IntraSight 797403Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00845225012878), received between May 5, 2021 and Aug 28, 2026 — classified as 1 injury, 81 malfunctions.

The most frequently reported specific device problem is “Sharp Edges” (55 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507580 ↗
• MalfunctionJun 16, 2026Overheating of Device

  IT WAS REPORTED THAT THE INTRASIGHT SYSTEM EXPERIENCED A HARDWARE ERROR CODE DURING SET UP. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. A PHILIPS FIELD SERVICE ENGINEER WAS ONSITE TO INSPECT THE INTRASIGHT AND FOUND DAMAGED/BROKEN CONNECTIONS ON THE ACE BOARD, ALONG WITH A BURNT PC WIRE (CONFIRMED FROM PHOTO RECEIVED). THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO A BURNT COMPONENT; POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25527311 ↗
• MalfunctionMay 13, 2026No Device Output

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM WAS USED IN A PROCEDURE. DURING USE, THE AO PRESSURE WAS NOT SHOWING ON THE MONITOR. THE PROCEDURE WAS ABORTED 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 25164964 ↗
• MalfunctionMay 1, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM TOUCHSCREEN MONITOR HAS PHYSICAL DAMAGE AND DOES NOT WORK. 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 25060644 ↗
• MalfunctionMay 1, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM TOUCHSCREEN MONITOR WAS CRACKED AND 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 25060301 ↗
• MalfunctionApr 30, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM TOUCHSCREEN MONITOR WAS CRACKED ON THE CORNER AND THE CABLE BROKE AT THE CONNECTION POINT. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR AND CABLE WERE RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE MONITOR CONFIRMED A CRACK WITH MISSING SCREEN MATERIAL, RESULTING IN SHARP EDGES. FOR THE CABLE, DAMAGE WAS CONFIRMED ON THE CONNECTOR. 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 25051196 ↗
• MalfunctionApr 22, 2026No Device Output

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM WAS USED IN A PERIPHERAL PROCEDURE. DURING USE, AN IVUS CATHETER WAS PLUGGED INTO THE PIM, BUT COULD NOT BE RECOGNIZED. THE PROCEDURE WAS ABORTED 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 24955172 ↗
• MalfunctionMar 20, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT 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 24656209 ↗
• MalfunctionMar 20, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT 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 24654860 ↗
• MalfunctionMar 13, 2026No Device Output

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM WAS USED IN A CORONARY PROCEDURE. DURING USE, THE YELLOW WAVE FORM (PD) WOULD NOT APPEAR ON THE SYSTEM. THE CASE WAS ABORTED AND THE PATIENT WILL BE RESCHEDULED FOR A LATER DATE. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE INTRASIGHT 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 24597959 ↗
• MalfunctionMar 6, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM TOUCHSCREEN MONITOR WAS DROPPED AND CRACKED DURING EQUIPMENT MOVEMENT. THERE WAS NO PATIENT PRESENT AND NO USER INJURY REPORTED. THE TOUCHSCREEN MONITOR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION CONFIRMED A CRACK WITH SHARP EDGES OBSERVED. 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 24536152 ↗
• MalfunctionMar 5, 2026Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM TOUCHSCREEN MONITOR BROKE. 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 24524929 ↗
• MalfunctionMar 5, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT 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 24521179 ↗
• MalfunctionFeb 19, 2026Computer Operating System Problem

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM WAS USED IN AN EMERGENT PROCEDURE. DURING USE, THE HEMO SIGNAL WAS UNSTABLE, AND WHEN RECONNECTING THE FM-PIM, THE SYSTEM HAD A "CONNECT FM-PIM" MESSAGE; THEREFORE, USE OF IFR WAS ABORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE SYSTEM COULD NOT BE USED DURING AN EMERGENT CASE, RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390961 ↗
• MalfunctionFeb 18, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT 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 24379851 ↗
• MalfunctionFeb 18, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT SYSTEM TOUCHSCREEN MONITOR WAS CRACKED ON THE EDGE. 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 24378492 ↗
• MalfunctionFeb 18, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT SYSTEM TOUCHSCREEN MONITOR WAS CRACKED IN THE UPPER LEFT CORNER. 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 24378223 ↗
• MalfunctionFeb 18, 2026Sharp Edges

  IT WAS REPORTED THAT THE INTRASIGHT SYSTEM TOUCHSCREEN MONITOR NOT RESPONDING TO TOUCH. ADDITIONALLY, WHEN PHILIPS FSE WAS ONSITE, A CRACKED SCREEN WAS OBSERVED. 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 24378211 ↗
• MalfunctionFeb 10, 2026Computer Operating System Problem

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM WAS USED IN AN EMERGENT STEMI PROCEDURE. DURING USE, THE SYSTEM HAD AN ERROR MESSAGE (IVUS IS NOT AVAILABLE); THEREFORE, IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A MOBILE SYSTEM. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE SYSTEM COULD NOT BE USED DURING AN EMERGENT CASE, RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24308135 ↗
• MalfunctionJan 27, 2026Computer Operating System Problem

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM WAS USED IN AN EMERGENT AORTIC DISSECTION PROCEDURE. DURING USE, THE SYSTEM HAD AN UNKNOWN HARDWARE ERROR; THEREFORE, IT COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A MOBILE C-ARM AND ANGIO. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE SYSTEM COULD NOT BE USED DURING AN EMERGENT CASE, RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193459 ↗
• MalfunctionJan 23, 2026Visual Prompts will not Clear

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM WAS USED IN AN EMERGENT PROCEDURE. DURING USE, AN ERROR MESSAGE WAS DISPLAYED ON THE MONITOR, EVEN AFTER MULTIPLE ATTEMPTS TO REBOOT THE SYSTEM. THE PROCEDURE WAS COMPLETED WITHOUT THE IVUS SYSTEM. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE SYSTEM COULD NOT BE USED DURING AN EMERGENT CASE; RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24171200 ↗
• MalfunctionJan 9, 2026No Device Output

  IT WAS REPORTED THAT AN INTRASIGHT SYSTEM WAS USED IN A CORONARY PROCEDURE. DURING USE, THE PD VALUE WAS INACCURATE, VALUE WAS DRIFTING, AND UNABLE TO NORMALIZE. THE IFR PROCEDURE WAS ABORTED AND THE PATIENT WILL BE TREATED IN A DIFFERENT LAB, SCHEDULED TWO DAYS LATER. NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED BECAUSE THE PROCEDURE WAS ABORTED, RESULTING IN A POTENTIAL FOR HARM DUE TO THE DELAY OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030930 ↗
• MalfunctionDec 24, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT 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 23889380 ↗
• MalfunctionDec 24, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT 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 23888601 ↗
• MalfunctionDec 12, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT AN INTRASIGHT 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 23794990 ↗