Emprint HP CAGENHPRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521781276), received between Jul 25, 2021 and Aug 27, 2026 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 18, 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.

• InjuryAug 27, 2026Device Alarm System; Adverse Event Without Identified Device or Use Problem

  It was reported that a high-temperature alert occurred and stopped the procedure. The team confirmed that the cooling system was working and that the fluid was circulating properly. Customer also replaced the fluid with one that had been previously stored in the refrigerator, but the problem persisted. Also pressed the reset button in an attempt to reset the alarm, but this was ineffective. Therefore, the procedure was completely discontinued and was rescheduled.

  Patient problems: Insufficient Information

  MAUDE report 50474846 ↗
• MalfunctionMay 1, 2026Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LIVER ABLATION PROCEDURE WAS PLANNED AND THE PATIENT WAS ALREADY UNDER SEDATION WHEN THE SYSTEM WAS POWERED ON AND COMPLETED AN AUTOMATIC TEST, WITH THE ANTENNA NOT INSERTED IN THE PATIENT. THE SYSTEM WAS REPORTED TO HAVE STOPPED WORKING WHEN THE GREY REUSABLE CONNECTION CABLE WAS INSERTED INTO THE GENERATOR, AN ALARM AND PERSISTENT ERROR MESSAGE, ¿ANTENNA TEMPERATURE PROBE LIMIT EXCEEDED,¿ APPEARED AND COULD NOT BE DISMISSED, AND THE USER REVIEWED AND TRIPLE-CHECKED THE PROCEDURE PROTOCOL AND HAD A COLLEAGUE VERIFY THE STEP-BY-STEP PROTOCOL, CONFIRMING IT WAS FOLLOWED. TROUBLESHOOTING WAS PERFORMED BY REPLACING THE REUSABLE CONNECTION CABLE, REPLACING THE DISPOSABLE PROBE, AND POWER-CYCLING THE SYSTEM MULTIPLE TIMES, BUT THE ERROR PERSISTED. SODIUM CHLORIDE (NACL) 1 LITER WAS ALSO CONNECTED, AND THE NACL CHAMBER WAS HALF FULL, THE PUMP WAS RUNNING, AND IT COULD BE SEEN THE NACL FLOWING IN THE CHAMBER. TWO STERILE ANTENNAS WERE OPENED AND NOT USED. THE PROCEDURE WITH THE DEVICE WAS ABORTED, AND TREATMENT WAS STARTED USING A NON-MEDTRONIC GENERATOR, WHICH CAUSED A DELAY AND EXTRA TIME FOR ABOUT 1 TO 1.5 HOURS. ADDITIONALLY, REPLACEMENT GENERATOR WAS DELIVERED BY

  Patient problems: Insufficient Information

  MAUDE report 25056175 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER ABLATION, A PSEUDOANEURYSM OCCURRED. A 10MM TUMOR LOCATED ABOUT 8MM FROM A BLOOD VESSEL WAS TREATED WITH 150W FOR 30 SECONDS. AFTER TREATMENT, DOPPLER CONFIRMED BLOOD FLOW IN THE ABLATION AREA. ALTHOUGH THE LIVER IS A PARENCHYMAL ORGAN, IT WAS BELIEVED THAT IT FORMED A PSEUDOANEURYSM AS BLOOD INFILTRATED THE ABLATION AREA. THERE WAS NO INTRAPROCEDURAL IMAGING PERFORMED DURING THE ABLATION. AN ADDITIONAL ABLATION WAS PERFORMED TO PREVENT BLOOD LEAKAGE FROM THE PUNCTURE ROUTE. FOR THE PSEUDOANEURYSM, THERE WAS SLIGHT LEAKAGE INTO THE ABDOMINAL CAVITY, BUT IT DID NOT RUPTURE SIGNIFICANTLY. HEMOSTASIS WAS ACHIEVED BY ANGIOGRAPHY PERFORMED BY AN INTERVENTIONAL RADIOLOGY (IVR) PHYSICIAN AND THE PATIENT¿S CONDITION SUBSEQUENTLY STABILIZED. AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT HAS BEEN TO THE OUTPATIENT CLINIC ONCE, AND THE PROGRESS HAS BEEN FINE EVEN THEN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm; Unintended Radiation Exposure

  MAUDE report 23767960 ↗
• InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OPERATIVELY, PATIENT EXPERIENCED PSEUDOANEURYSM. HEMOSTASIS PROCEDURE WITH ANGIOGRAPHY WAS PERFORMED. PATIENT CURRENT STATUS SHOWED NO PROBLEMS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm; Unintended Radiation Exposure

  MAUDE report 23767664 ↗
• MalfunctionApr 18, 2025Device Alarm System; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available; Device Alarm System; No Apparent Adverse Event; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED WHILE THE PATIENT WAS UNDER ANESTHESIA DUE TO AN ALARM ISSUE. THERE WAS A TEMPERATURE ISSUE DISPLAYED ON THE SCREEN WHEN THE DEVICE WAS APPLIED WITH THE CONNECTOR. SEVERAL ATTEMPTS WERE MADE TO RECONNECT, BUT THE SCREEN CONTINUED TO SHOW THE TEMPERATURE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21867498 ↗
• MalfunctionNov 27, 2024Smoking; Appropriate Device Problem Term/Code Not Available; Noise, Audible; Smoking; Appropriate Device Problem Term/Code Not Available; Noise, Audible

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE GENERATOR DURING ABLATION AT 150W WAS MAKING CONCERNING NOISES AND WAS EMITTING BURNING SMELL. THE SURGERY WAS COMPLETELY CANCELLED AS SOON AS IT WAS NOTICED THAT THERE WAS A PROBLEM WITH THE USE OF THIS GENERATOR. IT WAS ALSO FURTHER REPORTED THAT THE PATIENT WAS NOT UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 20800530 ↗
• InjurySep 4, 2024Smoking; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Smoking; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THE UNITS HAD BURNING SMELL AND STOPPED WORKING. THE PROCEDURE WAS CANCELLED AND WAS PUT UP IN SOME OTHER TIME. PATIENT ALREADY UNDER ANESTHESIA AT THE TIME OF THE EVENT. THE UNITS WERE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 20134778 ↗
• InjuryAug 15, 2024Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, ONCE THE SYSTEM WAS SET, THE PHYSICIAN TESTED THE ANTENNA, AND THE GENERATOR IMMEDIATELY DISPLAYED THE RED WARNING SIGN ALARM WITH THE NUMBER 4 AND 3 NEXT TO IT. AFTER REBOOTING THE GENERATOR, SAME ALARM OCCURRED, SO THE ANTENNA WAS DISCARDED AND NEEDED TO BE REPLACED BY A NEW ONE. ON THE PHOTO PROVIDED, A TRIANGLE ERROR SIGN WITH A NUMBER 4 AND 3 CAN BE SEEN. THE ISSUE LED TO A CANCELLED PROCEDURE WITH THE PATIENT UNDER ANESTHESIA AND RESCHEDULED. THE USED ANTENNA WAS TESTED WITH ALL THE OTHER PARTS OF THE SYSTEM AND THE GENERATOR WAS THE ONLY FAILING PART.

  Patient problems: Insufficient Information

  MAUDE report 19990296 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ABLATION LIVER PROCEDURE, THERE WAS A "BURST" IN THE ABDOMINAL CAVITY OF THE PATIENT LEADING TO LOCAL BLEEDING. IMMEDIATE BLEEDING CONTAINMENT AND CHANGE OF PROCEDURE TECHNIQUE WAS DONE TO COMPLETE THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18573992 ↗
• InjuryOct 4, 2023Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection 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 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 17869444 ↗
• 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 16904384 ↗
• InjuryFeb 16, 2023Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE SURGERY DURING PREPARATION, THE UNIT HAD MISSING PIN IN THE REUSABLE CABLE CONNECTOR ON THE FRONT OF THE GENERATOR. THE LOCKING REUSABLE HIGH EFFICIENCY CABLE HAD THE PIN STUCK INSIDE THE CABLE WHICH BROKE A SECOND, GEN 1 GENERATOR. PATIENT RECEIVED Y90 TREATMENT INLINE OF MALFUNCTION WITH EMPRINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 16386603 ↗
• MalfunctionDec 28, 2022Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Misassembly During Maintenance/Repair; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Misassembly During Maintenance/Repair

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE IN THE LIVER FOR HEPATOCELLULAR CARCINOMA, THE UNIT WAS RETURNED FROM PREVENTATIVE MAINTENANCE BUT WAS LEFT IN SERVICE MODE. THE UNIT WAS WORKING WELL BEFORE BEING SENT IN FOR ANNUAL PREVENTATIVE MAINTENANCE. THIS CAUSED SIGNIFICANT DELAYS TO THE PROCEDURE. THE GENERATOR DID NOT ABLATE AS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM WITH ERRORS ("GENERAL WARNING" AND "EXTERNAL CONTROL"), DESPITE FOLLOWING THE ALERT SHEET AND SHUTTING DOWN THE SYSTEM FOR TEN MINUTES. THE ANTENNA HAD BEEN POSITIONED TO THE PATIENT. THE PROCEDURE WAS DELAYED FOR 1 HOUR. THE SALES REPRESENTATIVE WENT TO THE HOSPITAL AND TESTED THE GENERATOR WITH A NEW EMPRINT ANTENNA AND THE SAME ALARMS STILL APPEARED. THE GENERATOR WAS ALSO TESTED INDEPENDENTLY OF THE HP CART AND THE ALARMS STILL APPEARED AND WOULD NOT ALLOW THE ABLATION TO PROCEED. THEY USED A COMPETITOR PRODUCT INSTEAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060851 ↗
• MalfunctionOct 18, 2021Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE WHEN THE GENERATOR WAS TURNED ON, THE UNIT GAVE A RED TRIANGLE ERROR MESSAGE. THE PATIENT WAS UNDER ANESTHESIA AND THE PROCEDURE NEEDED TO BE ABORTED WHEN THE ERROR OCCURRED. THE PATIENT WAS BROUGHT BACK LATER IN THE DAY TO BE TREATED WITH AN ALTERNATIVE GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647778 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE FIRST CASE, THERE WAS A REPORTED 8CM BURN ON A CEROTIC LIVER PATIENT. THE DEVICE USED 150 WATTS FOR ABLATION AND IT LACERATED THE PATIENT'S LIVER. THE PATIENT WAS UNDER ANESTHESIA AND THE PROCEDURE NEEDED TO BE ABORTED WHEN THE LIGHTS CAME ON. THEY REPLACED THE GENERATOR AND THE PATIENT WAS BROUGHT BACK LATER IN THE DAY TO BE TREATED WITH AN ALTERNATIVE EMPRINT GENERATOR. A LIVER SCAN WAS PROVIDED AND THE THE FIRST IMAGE WAS THE LAST AXIAL IMAGE THROUGH THE LIVER AT THE END OF THE PROCEDURE. YOU CAN SEE SOME BLOOD AROUND THE LIVER IN THIS IMAGE. THE NEXT THREE IMAGES ARE FROM ABOUT FOUR HOURS LATER WHEN THEY REPEATED THE IMAGES. THEY SHOWED A SIGNIFICANT INCREASE IN BLOOD AROUND THE LIVER.

  Patient problems: Burn(s); Laceration(s)

  MAUDE report 12521177 ↗
• InjuryJul 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY OF AN ABLATION PROCEDURE, THE PATIENT DEVELOPED AN ABSCESS NEAR THE ABLATION SITE IN THE LIVER. THEY ALSO DISCOVERED A FISTULA LOCATED NEAR THE COLON. THE PATIENT WAS GIVEN ANTIBIOTICS AND IS IN STABLE CONDITION. THEY PERFORMED FOUR ABLATIONS AT UNKNOWN WATTAGE.

  Patient problems: Abscess; Fistula

  MAUDE report 12223034 ↗