Emprint CAGEN1Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10884521190771), received between Mar 28, 2017 and May 20, 2026 — classified as 2 deaths, 25 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (13 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 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  IT WAS REPORTED THAT DURING THE ABLATION PROCEDURE, THE DEVICE STOPPED/SHUT OFF SEVERAL TIMES WHILE BURNING THE TUMOR. WHEN ATTEMPTING TO RESTART THE ABLATION, THE ¿SWITCH IS CLOSED¿ LIGHT APPEARED. ATTEMPTED TO RESTART THE DEVICE SEVERAL TIMES, WHICH ALLOWED TO CONTINUE FOR A WHILE. HOWEVER WHEN ATTEMPTING TO BURN THE CANAL, THE MACHINE STOPPED EACH TIME IT WAS RESTARTED AND EVENTUALLY SURGEON GAVE UP ENTIRELY. AS A RESULT, THE TUMOR TREATMENT WAS COMPLETED, BUT THE CANAL COULD NOT BE FULLY ABLATED BECAUSE THE DEVICE KEPT STOPPING. THE PATIENT WILL RETURN FOR A FOLLOW-UP SCAN IN 6 MONTHS FOR FURTHER EVALUATION.

  Patient problems: Insufficient Information

  MAUDE report 25229025 ↗
• MalfunctionNov 19, 2024Overheating of Device; Device Displays Incorrect Message; Temperature Problem; Overheating of Device; Device Displays Incorrect Message; Temperature Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD ERROR SIGNAL (RED WARNING LIGHT, NOT YELLOW) OF OVERHEATING. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DEVICE TRIPPED DURING MICROWAVE POWER CALIBRATION. THE FAULT WAS TRACED TO SOLDER JOINTS U38 SHIFT REGISTER IC PACK ON THE LEFT 84 EXTENDED POWER DISTRIBUTOR(EPD) PCA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20726331 ↗
• InjuryOct 4, 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, AFTER INSERTING THE ANTENNA INTO THE KIDNEY THE GENERATOR GAVE A WARNING OF A FAILURE WITH A RED TRIANGULAR LIGHT WAS LIT. THE DOCTOR DECIDED NOT TO WAIT FOR A REPLACEMENT DEVICE WITHIN 45 MINUTES AND DECIDED TO STOP THE OPERATION AND CANCEL IT DUE TO THE COMPLEXITY OF THE PATIENT. DUE TO THE INSERTION OF THE NEEDLE THROUGH THE SKIN INTO THE TUMOR AREA, A SLIGHT BLEEDING OCCURRED WHICH WAS CONTROLLED, THE PATIENT WAS LEFT FOR OBSERVATION UNTIL THE EVENING AND WAS RELEASED TO HER HOME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20376423 ↗
• InjurySep 11, 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 PROCEDURE, ATTEMPTED ABLATION ON CAGEN1 GENERATOR AND UNABLE TO ABLATE WITH A "?" ERROR. SWITCHED TO EMPRINT SX MACHINE AND RECEIVED ANTENNA STATE = 4 THERMAL LIMIT EXCEEDED AND ABLATION STATE = 16 GENERAL ERROR CODES. AFTER OPENING THE THIRD ANTENNA AND UNABLE TO ABLATE, THE PROCEDURE WAS ABORTED (PATIENT UNDER ANESTHESIA) AND PATIENT WAS UNABLE TO GET ABLATION PROCEDURE, BUT THE SURGEON MOVED FORWARD WITH DISSECTION PROCEDURE/LIVER RESECTION. LESION REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 20196287 ↗
• InjuryJul 12, 2024Device Alarm System; Overheating of Device; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Overheating of Device; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING ABLATION AFTER FIRST CT SCAN TO VERIFY THE KIDNEY LESION WHEN THE SURGEON MARK THE PROCEDURE AREA AND TURNING THE DEVICE ON, THE OVERHEAT ALARM START SOUND AND AFTER THAT RESET THE SYSTEM ON RESET BUTTON AND RE-TRIED TO TURN BACK ON THE SYSTEM AND THE OVERHEAT ALARM RETURN BACK. PATIENT WAS ALREADY UNDER ANESTHESIA AND THE SURGEON CANCELLED THE KIDNEY ABLATION AND RESCHEDULED TO (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 19735821 ↗
• 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 19342999 ↗
• MalfunctionApr 24, 2024No Flow; No Apparent Adverse Event; No Flow; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, THE UNIT'S PUMP DID NOT ENGAGE WHEN ENERGIZED INITIALLY. SYSTEM STOPPED AND RESTARTED, AND THE DEVICE BEHAVED IN THE SAME WAY. UNIT WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 19172855 ↗
• InjuryApr 15, 2024Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE AT 100W FOR 7 MINUTES PROTOCOL, WITH EVERY PROCESS CHECKED, WORKED UNTIL THE 6TH MINUTE THEN RED SIGN GENERAL WARNING, MADE THE PHYSICIAN UNABLE TO FINISH THE PROCEDURE EVEN AFTER RESTARTING THE GENERATOR AFTER 10 MINUTES SWITCHED OFF. NO ABNORMAL HEAT, ONLY ONE GENERAL ALARM SIGN, STEADY. THE FACILITY WAS WAITING FOR THE POST OP CT-SCAN COMING IN 6 WEEKS TO ASSESS IF PROCEDURE DESTRUCTION COVERED THE CANCER LESION ENOUGH, OTHERWISE PERIPHERAL RELAPSE WOULD BE DUE THE ANTENNA MALFUNCTIONING. PROCEDURE WAS ABORTED. WHEN THE PROCEDURE WAS PERFORMED AFTER IT WAS POSTPONED, THE FACILITY USED THE DEMO GENERATOR WITH THEIR CABLE AND PUMP, AND EVERYTHING WORKED FINE. ON THE OTHER HAND, THE WORKING ANTENNA AND TEST THE GENERATOR WITH SALES REP CABLE AND PUMP, AND THE GENERATOR WAS STILL SHOWING A RED ALARM SIGN.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19111568 ↗
• 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 19110633 ↗
• InjuryFeb 29, 2024Energy Spectrum Incorrect; Appropriate Device Problem Term/Code Not Available; Energy Spectrum Incorrect; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT KEPT RESETTING. EVERY 3-4 SECONDS, THE TIME AND WATTS RESET. TRIED DISCONNECTING AND RECONNECTING THE REUSABLE CABLE. CYCLED THE POWER. DISCONNECTED AND RECONNECTED THE POWER. TRIED A DIFFERENT POWER SOURCE. DEVICE CONTINUES TO RESET. PROCEDURE HAD TO BE ABORTED AFTER ONE ABLATION. PROCEDURE WILL BE RESCHEDULED.

  Patient problems: Insufficient Information

  MAUDE report 18812903 ↗
• InjuryJun 13, 2023Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE UNIT HAD AN ALERT CODE. THE ALERT CODE STATES THAT THE ANTENNA TEMPERATURE LIMIT HAS EXCEEDED. IT WAS ALSO STATED BY THE NURSE THAT THE UNIT CUTS OFF DURING OPERATION AND TURNS OFF. THEY HAD TO CANCEL THE CASES BECAUSE OF THE ISSUE. THE PROCEDURE WAS RESCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17118927 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING MICROWAVE ABLATION FOR A LIVER CANCER, THE PATIENT WITH A TUMOR LOCATED AT LOWER RIGHT LOBE, S6 HAD EXPERIENCED CARDIAC ARREST DURING MICROWAVE OUTPUT. THE PATIENT WAS REVIVED BUT CARDIAC ARREST OCCURRED EXACTLY WHEN THE OUTPUT STARTED. PATIENT'S HEART RATE SUDDENLY STOPPED, HOWEVER, THE PATIENT SEEMED TO HAVE SLIGHT BRADYCARDIA. THE PROCEDURE WAS PERFORMED UNDER GENERAL ANESTHESIA USING PROPOFOL, SO IT MIGHT BE THE EFFECT OF ANESTHESIA, BUT THE TIMING WAS EXACTLY WHEN THE OUTPUT STARTED. THE GROUNDING PAD WAS LOCATED AT FEMUR OF THE RIGHT LEG. IT DID NOT REQUIRE DEFIBRILLATION, ADDITIONAL TREATMENT NOR HOSPITALIZATION TO TREAT THE CARDIAC ARREST. PROCEDURE WAS COMPLETED AND PATIENT IS CURRENTLY ON A GOOD CONDITION.

  Patient problems: Bradycardia; Cardiac Arrest

  MAUDE report 17098582 ↗
• MalfunctionApr 21, 2023Connection Problem; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Connection Problem; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, AT START OF THE PROCEDURE, THE PATIENT WAS NOT YET ANESTHETIZED WHEN THE UNIT STOPPED WORKING AND THE CUSTOMER REALIZED THAT THE CABLE WOULD NOT HOOK WELL IN TO THE GENERATOR. THE PROCEDURE WAS SUSPENDED AND A NEW UNIT WAS REQUESTED THAT ARRIVED AFTER TWO DAY AND WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785128 ↗
• MalfunctionFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE ABLATION CATHETER WITH THERMOSPHERE TECHNOLOGY WERE RECALLED SINCE THE DEVICE WERE MISLABELED WITH THE INCORRECT EXPIRATION DATE.

  Patient problems: Insufficient Information

  MAUDE report 16410378 ↗
• MalfunctionFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN INJURY.

  Patient problems: Pneumothorax; Unspecified Tissue Injury

  MAUDE report 16404924 ↗
• MalfunctionFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE PATIENT HAD AN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16404920 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ARC POINT NEEDLE WAS NOTED TO HAVE PUNCTURED THE FISSURE LEADING TO PNEUMOTHORAX IN A NON MEDTRONIC PRODUCT. RIGHT CHEST DRAIN WAS INSERTED AND CHEMICAL PLEURODESIS AND THE PROCEDURE CONTINUED. FURTHER VENTOLIN AND AND HYDROCORTISONE WAS GIVEN. THE PATIENT PROLONGED THE HOSPITALIZATION.

  Patient problems: Pneumothorax

  MAUDE report 16404905 ↗
• MalfunctionFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16402571 ↗
• MalfunctionFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE ABLATION CATHETER WITH THERMOSPHERE TECHNOLOGY WERE RECALLED SINCE THE DEVICE WERE MISLABELED WITH THE INCORRECT EXPIRATION DATE.

  Patient problems: Insufficient Information

  MAUDE report 16402171 ↗
• MalfunctionFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO COMPLAINT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 16402126 ↗
• MalfunctionFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, MEDTRONIC RECALLED ABLATION CATHETER BECAUSE THE DEVICES WERE MISLABELED WITH THE INCORRECT EXPIRATION DATE OF 14JUN2023. THERE WAS NO PATIENT INVOLVEMENT. NOT A COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 16400983 ↗
• MalfunctionFeb 17, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, UNIT WAS DEFECTIVE. PATIENT'S SPO2: 98%.

  Patient problems: Insufficient Information

  MAUDE report 16400960 ↗
• MalfunctionFeb 17, 2023Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING ATTEMPT TO ABLATE AT 100W FOR 10 MINUTES, THERE WAS UNSUCCESSFUL DELIVERY OF ENERGY FROM THE ABLATION GENERATOR. TRIED THREE TIMES WITH PREMATURELY STOPPED AND CHANGED TO ANOTHER GENERATOR. PATIENT SPO2: 97%.

  Patient problems: Insufficient Information

  MAUDE report 16395971 ↗
• InjuryJan 27, 2023Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD AN ALERT CODE "THE ANTENNA TEMPERATURE LIMIT HAS EXCEEDED". THE IRCU SENIOR NURSES HAVE MENTIONED THAT THE MACHINE CUTS OFF AND THEY HAD TO CANCEL THE CASE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16258564 ↗
• InjuryJan 27, 2023Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD AN ALERT CODE THE ANTENNA TEMPERATURE LIMIT HAS EXCEEDED. THE INTERVENTIONAL RADIOLOGY CORONARY UNIT. (IRCU) SENIOR NURSES HAVE MENTIONED THAT THE MACHINE CUTS OFF AND THEY HAD TO CANCEL THE CASE AND WAS REBOOKED BUT THE DATE WAS UNKNOWN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252748 ↗