Emprint CA190RC1Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521190764), received between Mar 31, 2020 and Jul 22, 2024 — classified as 1 death, 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A MICROWAVE LIVER ABLATION, ANTENNA WAS POSITIONED IN PATIENT, ABLATION TIME AND POWER SET AND START BUTTON PRESSED. TEMPERATURE ALARM ALERT OCCURRED STRAIGHT AWAY. ALL CONNECTIONS CHECKED, INCLUDING SALINE BAG, TUBING AND CABLE - ALL LOOKED FINE. TRIED TO RESET AND START ABLATION AGAIN, SAME TEMPERATURE ALARM APPEARED. ANTENNA WAS REMOVED FROM PATIENT AND NEW ANTENNA AND SALINE BAG WAS USED BUT THE SAME TEMPERATURE ALARM OCCURRED AGAIN. PROCEDURE WAS ABANDONED AS NO ALTERNATIVE ABLATION SYSTEM TO USE. THE REUSABLE CABLE AND GENERATOR WERE TESTED AND CONNECTED TO A DEMO CATHETER. THE TEMPERATURE ALARM SHOWED STRAIGHT AWAY (WITHOUT PRESSING THE START ABLATION BUTTON). THE CABLE WAS REPLACED AND THERE WERE ABLE TO ABLATE WITH NO ISSUES. THE GENERATOR WAS ALSO USED ON DIFFERENT CASES AND SURGERIES WENT WELL. THE PATIENT WAS RESCHEDULED FOR ANOTHER SURGERY A WEEK AFTER WITHOUT ANY ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19794864 ↗
• InjuryJun 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING PERCUTANEOUS ABLATION PROCEDURE, THE PROCEDURE WAS CEASED. THE RADIOLOGIST WAS CONCERNED THAT THE THERAPEUTIC RANGE WAS NOT BEING MET WITH ANTENNA 1. HE WATER TESTED THE FIRST ANTENNA AND ACCORDING TO THE RADIOLOGIST, HE WAS NOT CONVINCED THAT THE ANTENNA WORKED, AND STAFF HAD TO OPEN ANOTHER ANTENNA TO ENSURE DELIVERY IN PREDICTABLE MARGINS. THE WATER TEST WAS DONE AFTER REMOVING THE SECOND ANTENNA FROM THE PATIENT AND THE RADIOLOGIST WAS NOT CONVINCED THAT THE EQUIPMENT WAS WORKING. THE GENERATOR WAS WORKING FINE WITH DIFFERENT CABLE AND A NEW ANTENNA. THE REPRESENTATIVE WAS CONTACTED AND WAS VERY HELPFUL WITH TROUBLESHOOTING BUT THE ANESTHETIST WANTED THE PROCEDURE TO BE CEASED AND REBOOKED. THE PATIENT WILL BE REBOOKED FOR THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19554569 ↗
• DeathMay 17, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE GENERATOR ALARMS SOUNDED AND IT DID NOT REACH THE TEMPERATURE. THE PROCEDURE WAS ABORTED-PATIENT UNDER ANESTHESIA AND COULD NOT BE PERFORMED BECAUSE THE PATIENT WAS BLEEDING. SURGEON CAUTERIZE THE BLEEDING. PATIENT WAS ADMITTED TO INTENSIVE CARE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19342977 ↗
• InjuryApr 15, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER A GENERATOR SHUT DOWN OF 1H, IT HAD BEEN RESTARTED FOR ANOTHER PATIENT. SAME GENERAL ALARM WAS PRESENT FROM THE START THIS TIME, BUT ONLY ON THE 100W SETTING. NO ALARM ON 75W SETTING, SO THE PROCEDURE HAD BEEN STARTED, BUT ABORTED BECAUSE THE PHYSICIAN HAD NO SIGN OF TREATMENT ON PER OP MEDICAL IMAGING (ULTRASOUND AND CT SCAN CONTROL), SO IT SEEMS 75W DID NOT WORK DESPITE LACK OF ALARM (2 ANTENNAS HAD BEEN USED DURING THIS PROCEDURE). THE PATIENT HAD TO BE RESCHEDULED AND TREATED.

  Patient problems: Insufficient Information

  MAUDE report 19112757 ↗
• InjuryApr 5, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, TEMPERATURE ALARM ACTIVATED AT THE ANTENNA CONNECTION, WHEN ALREADY POSITIONED IN THE PATIENT, EVEN AFTER ANTENNA CHANGED AND COOLING SYSTEM CHECKED, NO EFFECT FROM RESET BUTTON. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 19050924 ↗
• InjuryApr 2, 2024Device Alarm System; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, TEMPERATURE ALARM ACTIVATED AT THE ANTENNA CONNECTION (ELECTRONIC AND WATER COOLING SET), WHEN ALREADY POSITIONED IN THE PATIENT, EVEN AFTER ANTENNA WAS CHANGED, AND COOLING SYSTEM WAS CHECKED, THERE WAS NO EFFECT FROM RESET BUTTON. THE TWO ANTENNAS HAVE BEEN OPENED AND USED, AND THE REUSABLE CABLE SEEMED TO BE THE CAUSE OF THE FAILURE. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS ALREADY UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 19027056 ↗
• InjuryOct 18, 2023Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, WHEN THE CABLE WAS ATTEMPTED TO CONNECT TO THE ANTENNA CONNECTOR, THE CABLE SIDE DID NOT TURN AND IT COULD NOT BE CONNECTED. THERE WAS NO IMPROVEMENT EVEN WHEN USING ANOTHER ANTENNA. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS UNDER ANESTHESIA. THE SCHEDULE WAS CHANGED TO ANOTHER DATE AND COMPLETED WITHOUT ANY PROBLEMS.

  Patient problems: Insufficient Information

  MAUDE report 17957986 ↗
• InjuryOct 3, 2023Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO ANTENNAS HAS NOT BEEN DETECTED BY THE GENERATOR, AND THE "?" ALARM ("ANTENNA NOT IDENTIFIED") REMAIN DISPLAYED. CUSTOMER STATED THAT IT CAME FROM THE CABLE BECAUSE A PROCEDURE HAS BEEN PERFORMED SUCCESSFULLY PREVIOUSLY THE SAME DAY WITH THE SAME CABLE, AND AFTER THIS EVENT THE ANTENNA THAT WORKED ON THE PREVIOUS PROCEDURE WAS NOT IDENTIFIED ANYMORE AS THE TWO OTHERS, WHEREAS IT WAS WELL IDENTIFIED SOONER. PROCEDURE WAS CANCELLED - PATIENT WAS UNDER ANESTHESIA. IT IS PLANNED TO BE RESCHEDULED, BUT THE DATE REMAINS UNKNOWN YET. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862625 ↗
• MalfunctionMay 10, 2023Device Alarm System; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Device Alarm System; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING HEPATIC ARTERIOGRAM/MICROWAVE ABLATION OF THE LIVER DUE TO HCC, THE DEVICE KEPT SHOWING A TEMPERATURE ERROR. DOCTOR ATTEMPTED A 100 X 3.30 MINUTES. THE DEVICE STOPPED BURNING AT 2:21. THEN THE TEMPERATURE ERROR CAME ON. THEY WAITED SEVERAL MINUTES AND TEMP ERROR TURNED OFF. THEN THEY BURNED 150 FOR 1 MINUTE AND IT STOPPED AT 36 SECONDS. THEN TEMPERATURE ERROR CAME BACK ON. THEN AFTER WAITING SEVERAL MORE MINUTES THEY BURNED AGAIN 1 MINUTE FOR 100. THE PROBE WAS BRAND NEW AND THE TEMP ERROR CAME ON UPON CONNECTION TO THE GENERATOR. IT DISPLAYED A TEMPERATURE ERROR MESSAGE BUT THE CATHETER HAD NOT EVEN YET BEEN TESTED. REFLECTED POWER INTERLOCK TRIGGERED. INTERMITTENTLY IT WOULD FUNCTION AND ERROR MESSAGES WOULD COME ON THEN GO OFF. THE DOCTOR WAS NO LONGER COMFORTABLE WITH THE GENERATOR BASED ON NUMEROUS ERROR AND PROCEDURAL INTERRUPTIONS WITH 3 SEPARATE ANTENNAS. THE DEVICE WAS ENGINEERED IMPROPERLY. THE CONNECTOR END THAT CONNECTS THE GENERATOR TO THE ANTENNA CABLE WAS BACKWARDS AND THE ARROWS WOULD NO T ALIGN. PATIENT WAS UNDER ANESTHESIA SO THE TIME DELAYS KEPT HIM ANESTHETIZED FOR LONGER DURATION THAN WAS NECESSARY. DOCTOR WAS CONCERNED ABOUT T

  Patient problems: Insufficient Information

  MAUDE report 16904359 ↗
• MalfunctionDec 9, 2022Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ANTENNA DID NOT ACTIVATE AS THE ENERGY CABLE WAS DAMAGED. ALSO, THE GENERATOR HAD A TEMPERATURE ALARM ISSUE AND IT STOPPED IMMEDIATELY ONCE ABLATION WAS STARTED. IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS UNDER ANESTHESIA. IT WAS CONFIRMED BY THE FACILITY TECHNICIAN AND THE IN-HOUSE MEDICAL TECHNOLOGY THAT THE POWER CABLE WAS BROKEN AND HAD TRIGGERED THE ERROR MESSAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15953862 ↗
• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABLATION IN TUMOR LESION LOCATED ON SUPERIOR POLE OF THE LEFT KIDNEY, THE ANTENNA HAD BEEN DIFFICULT TO FIX TO THE REUSABLE CABLE, THE PLASTIC ROTATIVE FIXATION RING DID NOT WORK AS IT SHOULD BE. THE ANTENNA HAS BEEN DETECTED FOR FEW SECONDS, THEN NOT RECOGNIZE IN RESULT OF THE LACK OF FIXATION OF THE REUSABLE CABLE. DUE TO FIRST ANTENNA'S MALFUNCTION CAUSED BY THE REUSABLE CABLE, ANOTHER ANTENNA HAS BEEN USED WITH ANOTHER REUSABLE CABLE (FULLY FUNCTIONAL). BUT DUE TO FRAGILE VASCULAR STATE OF THE PATIENT AND HIS TUMOR, THE SECOND ANTENNA CAUSED IMPORTANT RETRO-PERITONEAL BLEEDING (RESOLVED THE SAME DAY LATER WITH NO COMPLICATION), THAT LEAD TO THE STOP OF THE PROCEDURE WHILE THE PATIENT IS UNDER ANESTHESIA. THE STOPPED FROM ITSELF, NO EMBOLIZATION NEEDED. THE PROCEDURE WAS RE SCHEDULED FOR THE NEXT DAY. TWO ANTENNAS HAS BEEN USED WITH NO RESULTS BECAUSE OF MALFUNCTION OF REUSABLE CABLE.

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 15675751 ↗
• InjuryOct 26, 2022Connection Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABLATION IN TUMOR LESION LOCATED ON SUPERIOR POLE OF THE LEFT KIDNEY, THE ANTENNA HAD BEEN DIFFICULT TO FIX TO THE REUSABLE CABLE, THE PLASTIC ROTATIVE FIXATION RING DID NOT WORK AS IT SHOULD BE. THE ANTENNA HAS BEEN DETECTED FOR FEW SECONDS, THEN NOT RECOGNIZE IN RESULT OF THE LACK OF FIXATION OF THE REUSABLE CABLE. DUE TO FIRST ANTENNA'S MALFUNCTION CAUSED BY THE REUSABLE CABLE, ANOTHER ANTENNA HAS BEEN USED WITH ANOTHER REUSABLE CABLE (FULLY FUNCTIONAL). BUT DUE TO FRAGILE VASCULAR STATE OF THE PATIENT AND HIS TUMOR, THE SECOND ANTENNA CAUSED IMPORTANT RETRO-PERITONEAL BLEEDING (RESOLVED THE SAME DAY LATER WITH NO COMPLICATION), THAT LEAD TO THE STOP OF THE PROCEDURE WHILE THE PATIENT IS UNDER ANESTHESIA. THE STOPPED FROM ITSELF, NO EMBOLIZATION NEEDED. THE PROCEDURE WAS RE SCHEDULED FOR THE NEXT DAY. TWO ANTENNAS HAS BEEN USED WITH NO RESULTS BECAUSE OF MALFUNCTION OF REUSABLE CABLE.

  Patient problems: Retroperitoneal Hemorrhage

  MAUDE report 15675286 ↗
• MalfunctionOct 5, 2022Energy Output Problem; No Apparent Adverse Event; Energy Output Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE GENERATOR SWITCHED ITSELF POWER AND TIME. IT ALWAYS SETS ITSELF TO 100W AND 10 SECONDS NO MATTER WHAT WAS PREVIOUSLY SET. IT HAD INTERMITTENT ACTIVATION. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS ALREADY UNDER ANESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544479 ↗
• MalfunctionJul 28, 2021Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE DEVICE CABLE RECEPTACLE (BLUE SIDE) CANNOT BE CONNECTED TO ANTENNA'S RECEPTACLE. THE PROCEDURE WAS CANCELLED - PATIENT UNDER GENERAL ANESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238283 ↗
• InjuryMay 7, 2020Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABLATION, THE ABLATION CABLE WAS DAMAGED WHEREIN IT COULD NOT BE CONNECTED WITH THE ANTENNA. THE P OCEDURE WAS ABORTED BUT THE PATIENT WAS IN GENERAL ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 10032901 ↗
• InjuryMar 31, 2020Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABLATION, THE CABLE COULD NOT BE CONNECTED WITH THE ANTENNA. PROCEDURE WAS ABORTED BUT THE PATIENT WAS UNDER GENERAL ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 9902167 ↗