CORE Series Precision Guided Therapy System 400-0100.02Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00845225010300), received between Apr 13, 2018 and Apr 2, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A CORE SYSTEM WAS USED IN A PROCEDURE. DURING USE, THERE WAS NO DISPLAY SINCE THE TOUCH PANEL WAS NOT WORKING. AFTER UNPLUGGING/PLUGGING IN THE CABLE TO THE CONTROL PAD, THE SYSTEM DID POWER ON BUT IT WAS TOO LATE INTO THE EXAM TO USE THE SYSTEM. THE PROCEDURE COULD NOT BE COMPLETED AND HAD TO BE RESCHEDULED. NO PATIENT INJURY WAS 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 21753153 ↗
• MalfunctionJan 28, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE FOR THE CORE SYSTEM, THE PRESSURE GUIDE WAS NOT WORKING PROPERLY. A FIELD SERVICE ENGINEER WAS ON SITE AND REPLACED THE BUB, AND THE SYSTEM WAS RETURNED FOR USE. THERE WAS NO PATIENT INVOLVEMENT AND NO USER INJURY REPORTED. DURING THE DEVICE EVALUATION, THERMAL DAMAGE WAS OBSERVED ON THE BUB (+24V CONNECTOR). THIS PRODUCT PROBLEM IS BEING REPORTED DUE TO THE CONFIRMED THERMAL DAMAGE, RESULTING IN A POTENTIAL FOR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261055 ↗
• InjuryJul 21, 2023Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT THE CORE SYSTEM LOST POWER HALFWAY THROUGH AN EMERGENT CORONARY PROCEDURE. THE ATTEMPT TO REGAIN POWER LASTED ABOUT 45 MINS TO AN HOUR. THE PATIENT WAS TRANSFERRED TO ANOTHER CATH LAB WITH AN OPERATING IVUS. THERE WAS NO REPORT OF PATIENT HARM. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SYSTEM POWER OUTAGE, RESULTING IN A DELAY OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17374954 ↗
• MalfunctionApr 20, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE CORE SYSTEM TOUCHSCREEN WAS SHATTERED. 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 16777551 ↗
• MalfunctionJun 6, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. AN INTERNAL REVIEW OF SIMILAR COMPLAINT DESCRIPTIONS REPORTED UNDER MDR 2939520-2018-00023 OF NO AO PRESSURE SIGNAL DISPLAYING PROMPTED A RE-INVESTIGATION OF THE RETURNED DEVICE AS A SIMILAR COMPLAINT. ON 05/07/2018, THE MANUFACTURES SR. MANUFACTURING ENGINEER WAS REQUESTED TO ASSIST WITH THE EVALUATION OF THE MANUFACTURES DEVICE BEDSIDE UTILITY BOX (BUB). VISUAL INSPECTION OF THE RETURNED BUB WAS PERFORMED. NO EXTERNAL PHYSICAL DAMAGE WAS OBSERVED. THE BUB COVER WAS REMOVED TO DISASSEMBLE FOR A CAREFUL INTERNAL EXAMINATION. NO BURNT SMELL WAS DETECTED BEFORE OR AFTER DISASSEMBLING THE DEVICE. DISCOLORATION AND DAMAGE WAS NOTICED ON THE CAPACITORS C94, C95 AND C96 AND THE CIRCUITRY AROUND CAPACITOR C95 THAT ARE LOCATED ON AN INTERNAL BOARD INSIDE THE MANUFACTURES DEVICE. CAPACITOR C95 WAS BURNT. CAPACITORS C94 AND C96 WERE DISCOLORED. ACCORDING, TO THE INSPECTION OF THE FAILED BUB, THE CAPACITORS (C94, C95, C96) APPEARED DISCOLORED AND DAMAGED DUE TO EXCESSIVE HEAT DUE TO THE CAPACITOR FAILING. MEASURING CONTINUITY OF TP23 AND TP21 TO GROUND USING MULTIMETER, IT WAS FOUND THAT THE 12V OUTPUT IS SHORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575995 ↗
• MalfunctionJun 6, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. AN INTERNAL REVIEW OF SIMILAR COMPLAINT DESCRIPTIONS REPORTED UNDER MDR 2939520-2018-00023 OF NO AO PRESSURE SIGNAL DISPLAYING PROMPTED A RE-INVESTIGATION OF THE RETURNED DEVICE AS A SIMILAR COMPLAINT. ON 05/07/2018, THE MANUFACTURES SR. MANUFACTURING ENGINEER, WAS REQUESTED TO ASSIST WITH THE EVALUATION OF THE MANUFACTURES DEVICE BEDSIDE UTILITY BOX (BUB). VISUAL INSPECTION OF THE RETURNED BUB WAS PERFORMED. NO EXTERNAL PHYSICAL DAMAGE WAS OBSERVED. THE BUB COVER WAS REMOVED TO DISASSEMBLE FOR A CAREFUL INTERNAL EXAMINATION. NO BURNT SMELL WAS DETECTED BEFORE OR AFTER DISASSEMBLING THE DEVICE. DISCOLORATION AND DAMAGE WAS NOTICED ON THE CAPACITOR (C95) THAT IS LOCATED ON AN INTERNAL BOARD INSIDE THE MANUFACTURES DEVICE. ACCORDING, TO THE INSPECTION OF THE FAILED BUB, THE CAPACITOR C95 APPEARED DISCOLORED DUE TO EXCESSIVE HEAT DUE TO THE CAPACITOR FAILING. MEASURING CONTINUITY OF TP23 AND TP21 TO GROUND USING MULTIMETER, IT WAS FOUND THAT THE 12V OUTPUT IS SHORTED. THE CIRCUIT IS DESIGNED TO NOT SUPPLY POWER IF A SHORT IS DETECTED. THE AO/ECG TWIN-AX CABLE CONNECTOR REQUIRES 12V TO POWER ON, SO THIS CON

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575988 ↗
• MalfunctionJun 6, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. AN INTERNAL REVIEW OF SIMILAR COMPLAINT DESCRIPTIONS REPORTED UNDER MDR 2939520-2018-00023 OF NO AO PRESSURE SIGNAL DISPLAYING PROMPTED A RE-INVESTIGATION OF THE RETURNED DEVICE AS A SIMILAR COMPLAINT. ON 05/07/2018, THE MANUFACTURES SR. MANUFACTURING ENGINEER, WAS REQUESTED TO ASSIST WITH THE EVALUATION OF THE MANUFACTURES DEVICE BEDSIDE UTILITY BOX (BUB). VISUAL INSPECTION OF THE RETURNED BUB WAS PERFORMED. NO EXTERNAL PHYSICAL DAMAGE WAS OBSERVED. THE BUB COVER WAS REMOVED TO DISASSEMBLE FOR A CAREFUL INTERNAL EXAMINATION. NO BURNT SMELL WAS DETECTED BEFORE OR AFTER DISASSEMBLING THE DEVICE. DISCOLORATION AND DAMAGE WAS NOTICED ON THE CAPACITOR (C95) THAT IS LOCATED ON AN INTERNAL BOARD INSIDE THE MANUFACTURES DEVICE. ACCORDING, TO THE INSPECTION OF THE FAILED BUB, THE CAPACITOR C95 APPEARED DISCOLORED DUE TO EXCESSIVE HEAT DUE TO THE CAPACITOR FAILING. MEASURING CONTINUITY OF TP23 AND TP21 TO GROUND USING MULTIMETER, IT WAS FOUND THAT THE 12V OUTPUT IS SHORTED. THE CIRCUIT IS DESIGNED TO NOT SUPPLY POWER IF A SHORT IS DETECTED. THE AO/ECG TWIN-AX CABLE CONNECTOR REQUIRES 12V TO POWER ON, SO THIS CON

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575979 ↗
• MalfunctionJun 6, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. AN INTERNAL REVIEW OF SIMILAR COMPLAINT DESCRIPTIONS REPORTED UNDER MDR 2939520-2018-00023 OF NO AO PRESSURE SIGNAL DISPLAYING PROMPTED A RE-INVESTIGATION OF THE RETURNED DEVICE AS A SIMILAR COMPLAINT. ON 05/07/2018, THE MANUFACTURES SR. MANUFACTURING ENGINEER, WAS REQUESTED TO ASSIST WITH THE EVALUATION OF THE MANUFACTURES DEVICE BEDSIDE UTILITY BOX (BUB). VISUAL INSPECTION OF THE RETURNED BUB WAS PERFORMED. NO EXTERNAL PHYSICAL DAMAGE WAS OBSERVED. THE BUB COVER WAS REMOVED TO DISASSEMBLE FOR A CAREFUL INTERNAL EXAMINATION. NO BURNT SMELL WAS DETECTED BEFORE OR AFTER DISASSEMBLING THE DEVICE. DISCOLORATION AND DAMAGE WAS NOTICED ON THE CAPACITOR (C95) THAT IS LOCATED ON AN INTERNAL BOARD INSIDE THE MANUFACTURES DEVICE. ACCORDING, TO THE INSPECTION OF THE FAILED BUB, THE CAPACITOR C95 APPEARED DISCOLORED DUE TO EXCESSIVE HEAT DUE TO THE CAPACITOR FAILING. MEASURING CONTINUITY OF TP23 AND TP21 TO GROUND USING MULTIMETER, IT WAS FOUND THAT THE 12 V OUTPUT IS SHORTED. THE CIRCUIT IS DESIGNED TO NOT SUPPLY POWER IF A SHORT IS DETECTED. THE AO/ECG TWIN-AX CABLE CONNECTOR REQUIRES 12 V TO POWER ON, SO THIS C

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7575975 ↗
• MalfunctionMay 17, 2018Thermal Decomposition of Device; Charred; Thermal Decomposition of Device; Charred

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THE TEMPERATURE OF BEDSIDE UTILITY BOX II (BUB) WHICH IS CONNECTED TO THE MANUFACTURER'S SYSTEM FEELS HOT. THE MANUFACTURER'S SALES REPRESENTATIVE CONFIRMED THE BUB POWER LED IS ON AND THE CCP2 CABLE IS PLUGGED IN TO THE V6 ON THE BUB. THE CCP2 DOES NOT POWER ON. THE REPRESENTATIVE IS NOT ABLE PERFORM THE ANALOG INPUT CALIBRATION. THE SYSTEM INDICATES CALIBRATION IS OUT OF RANGE. THE REPRESENTATIVE CONFIRMED THE ECG/BP PIGTAIL CABLE IS FULLY SEATED TO THE ANALOG OUTPUT CHANNEL OF THE EG MAC LAB HEMO SYSTEM AND THE ECG/BP Y CABLE IS FULLY SEATED AT THE BACK OF THE CPU. THERE WAS NO INJURY OR HARM TO THE USER(S). AS THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THERE IS NO PATIENT INVOLVEMENT. A FIELD SERVICE ENGINEER (FSE) FROM THE MANUFACTURER WAS SENT TO THE CUSTOMER SITE AND OBSERVED THE REPORTED COMPLAINT. THE SYSTEM WAS REPAIRED IN THE FIELD BY REPLACING THE BUB. THE FSE COMPLETED A TEST AND INSPECTION SERVICE CHECKLIST TO ENSURE THE SYSTEM OPERATED AS INTENDED. AT THE TIME OF THE FSE'S DEPARTURE FROM THE SITE THE SYSTEM WAS OPERATING AS INTENDED. A VISUAL INSPECTION OF THE RETURNED

  Patient problems: No Patient Involvement

  MAUDE report 7522320 ↗
• MalfunctionApr 13, 2018Thermal Decomposition of Device; Charred; Thermal Decomposition of Device; Charred

  THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER'S POLICY. IT WAS REPORTED THERE IS NO AO PRESSURE DISPLAYED ON THE MANUFACTURER'S SYSTEM. THERE WAS NO INJURY OR HARM TO THE USER(S). AS THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THERE IS NO PATIENT INVOLVEMENT. A FIELD SERVICE ENGINEER (FSE) FROM THE MANUFACTURER WAS SENT TO THE CUSTOMER SITE. THE FSE CONFIRMED THE REPORTED FAILURE BY ATTACHING TRANSDUCER AND APPLYING PRESSURE. THE SYSTEM WAS REPAIRED IN THE FIELD BY REPLACING THE BEDSIDE UTILITY BOX II (BUB). THE FSE COMPLETED A TEST AND INSPECTION SERVICE CHECKLIST TO ENSURE THE SYSTEM OPERATED AS INTENDED. AT THE TIME OF THE FSE'S DEPARTURE FROM THE SITE THE SYSTEM WAS OPERATING AS INTENDED AND THERE WERE NO OUTSTANDING ACTION ITEMS. THE SYSTEM WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. HOWEVER, THE BUB WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED BUB WAS PERFORMED. NO EXTERNAL PHYSICAL DAMAGE WAS OBSERVED. THE BUB WAS CONNECTED TO A FAILURE ANALYSIS (FA) LAB CORE SYSTEM FOR A FUNCTIONAL TEST. AN ECG/AO SIMULATOR WAS CONNECTED TO THE BUB TO SIMULATE THE ECG/AO SIGNALS. DURING FUNCTIONAL TESTING, THE LED ON THE

  Patient problems: No Patient Involvement

  MAUDE report 7431491 ↗