Emprint CA15L2 (UDI 10884521806542)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 10884521806542), received between Sep 23, 2021 and Sep 23, 2026 — classified as 1 death, 28 injuries, 37 malfunctions.

The most frequently reported specific device problem is “No Flow” (19 reports).

3 other recalls cover devices cleared under the same FDA submission (K163105); they may or may not involve this specific model.

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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device Alarm System; No Flow

  It was reported that during a thermo-ablation procedure, air bubbles persisted in the system despite needle purging performed according to the manufacturer¿s recommendations. The device entered error mode and displayed a ¿RESET¿ error message. Regular shutdowns of the thermo-ablation system, and multiple system restarts were required during the procedure.

  Patient problems: Insufficient Information

  MAUDE report 50868349 ↗
• MalfunctionMay 18, 2026Leak/Splash; Overheating of Device; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THERMOABLATION, THE NEEDLE OVERHEATED, CAUSING THE NEEDLE TIP TO MELT. WHEN THE NEEDLE WAS REMOVED, THERE WAS A LEAK IN THE COOLING SYSTEM. NOTHING FELL INTO PATIENT'S CAVITY SO NO X-RAY OR ADDITIONAL MEDICAL PROCEDURE WERE PERFORMED. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203519 ↗
• MalfunctionMay 1, 2026Device Alarm System; 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 25056373 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER COMPLETION OF AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED A BLEED. THE PATIENT REQUIRED AN EMBOLIZATION DUE TO THE BLEED. THE PROCEDURE WAS COMPLETED WITH THE DEVICE AND NO ALARM WAS NOTED. IT WAS INDICATED THAT THERE WAS NO TECHNICAL OR PERFORMANCE ISSUES WITH THE DEVICE AND THAT THE BLEED MAY HAVE BEEN RELATED TO TECHNIQUE, AS THE SURGEON WAS USING A NON-MEDTONIC ROBOTICS DEVICE. PATIENT WAS REPORTED TO BE ALIVE AND STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24570251 ↗
• InjuryFeb 23, 2026Device Alarm System; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING MICROWAVE TREATMENT OF A LIVER LESION USING COMPUTED TOMOGRAPHY SCAN, THE DEVICE STOPPED DURING TREATMENT WITH 3 MINUTES AND 56 SECONDS REMAINING OF A PLANNED 10-MINUTE SESSION, AND THE TEMPERATURE INDICATOR LIGHT WAS ACTIVATED. THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WAS NO RESCHEDULED DATE YET. ADDITIONALLY, THE GENERATOR WORKED WELL WITH A DIFFERENT ANTENNA/PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24414529 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE ABLATION CYCLE WAS COMPLETED. BUT THERE WAS A MILD/SIGNIFICANT EXPLOSION OCCURRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 23957868 ↗
• MalfunctionDec 23, 2025No Flow; Intermittent Energy Output; No Flow; Intermittent Energy Output

  IT WAS REPORTED THAT DURING ABLATION, THE DEVICE STOPPED WORKING AND A BUBBLE WAS OBSERVED IN THE COOLING SYSTEM. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A NEW DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878299 ↗
• InjuryDec 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, ANTENNA FRAGMENT WAS FOUND INSIDE THE LIVER. THERE WERE NO SERIOUS COMPLICATIONS IN THE PATIENT DUE TO PRODUCT FAILURE, AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING WELL.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 23681708 ↗
• MalfunctionNov 13, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING A PROCEDURE COOLING FAILED TO CIRCULATE AFTER REPOSITIONING THE ANTENNA, WHICH TRIGGERED A HEAT ERROR MESSAGE. THE FIRST ABLATION WAS COMPLETED SMOOTHLY, BUT THE ISSUE AROSE UPON REPOSITIONING. THE ANTENNA WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543982 ↗
• MalfunctionNov 10, 2025Device Alarm System; Leak/Splash; No Flow; Device Alarm System; Leak/Splash; No Flow

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE INVOLVING THE DEVICE, A FAULTY ANTENNA WAS IDENTIFIED WHEN THE TEMPERATURE ALARM CONTINUED TO TRIP. CONTINUOUS AIR BUBBLES WERE OBSERVED IN THE RESERVOIR OF THE FAULTY ANTENNA, AND A LEAK WITHIN THE TUBING WAS NOTED, CAUSING AIR BUBBLES AND INSUFFICIENT COOLING OF THE ANTENNA. MULTIPLE TROUBLESHOOTING ACTIONS WERE PERFORMED, INCLUDING SWITCHING OUT THE GENERATOR, PUMP, REUSABLE CABLE, AND SALINE BAG, BUT THE ISSUE PERSISTED UNTIL A SECOND ANTENNA WAS USED, WHICH FUNCTIONED WITHOUT TEMPERATURE ALARMS. THE ABLATION PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE REPLACEMENT ANTENNA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510857 ↗
• MalfunctionOct 16, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING PROCEDURE, COOLING DID NOT WORK AND THE DEVICE FAILED TO CIRCULATE. THE PUMP WAS RUNNING, BUT THE SYSTEM FAILED OUT. THE ISSUE WAS RESOLVED BY CHANGING THE ANTENNA, AFTER WHICH THE SYSTEM FUNCTIONED PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309820 ↗
• MalfunctionAug 19, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE DEVICE FAILED TO CIRCULATE AND WOULD NOT FLUSH THROUGH WITH SALINE. THE TEAM ATTEMPTED TROUBLESHOOTING BY DISCONNECTING AND RECONNECTING ALL CONNECTIONS, BUT THE ISSUE PERSISTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840246 ↗
• InjuryAug 15, 2025Leak/Splash; Loose or Intermittent Connection; Detachment of Device or Device Component; Leak/Splash; Loose or Intermittent Connection; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE AT 125W/10 MIN, AND AFTER REPOSITIONING AT 125W/MIN, A COMPONENT OF THE DEVICE BECAME LOOSE. IT WAS ALSO NOTICED THAT COOLING LIQUID (NACL) WAS LEAKING FROM THE ANTENNA, BUT THE CAUSE COULD NOT BE IDENTIFIED UNTIL THE ANTENNA WAS REMOVED. THE PHYSICIAN CONFIRMED THAT THEY HAD ALLOWED THE ANTENNA TO COOL DOWN FOR AT LEAST 10 SECONDS AND HAD ROTATED IT CLOCKWISE AND COUNTERCLOCKWISE BEFORE REMOVAL. UPON REMOVAL, IT WAS NOTICED THAT THE TIP OF THE ANTENNA HAD BROKEN OFF. THE X-RAY WAS PERFORMED TO LOCATE THE BROKEN PIECE AND FOUND IN PATIENT'S LIVER. THE SURGEON DECIDED THAT IT WAS TOO RISKY TO REMOVE THE TIP, SO THE BROKEN PIECE WAS LEFT REMAINED IN THE PATIENT'S LIVER. THE PROCEDURE WAS COMPLETED WITH THE INCIDENT DEVICE.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 22816411 ↗
• InjuryJul 3, 2025Device Alarm System; Leak/Splash; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Leak/Splash; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A RENAL TUMOR ABLATION PROCEDURE USING THE EMPRINT NEEDLE, THE CERAMIC TIP OF THE ABLATION NEEDLE DETACHED AND REMAINED WITHIN THE RENAL MASS. THE PROCEDURE WENT FINE AND THERE WERE NO ISSUES. SIMPLE INSERTION THROUGH A WELL-SIZED SKIN INCISION, NO EXCESS FORCE WHATSOEVER ON THE NEEDLE. NEEDLE WAS INSERTED IN REAL-TIME UNDER ULTRASOUND, THE ECHOGENIC NEEDLE TIP WAS CLEARLY PRESENT AT PROCEDURE START. AT 8.20 MINUTES THROUGH A 10 MINUTES 150W CYCLE, THE NURSE NOTICED THE FLUID IN THE 500 CC BAG WAS OUT, A SECOND OR TWO LATER THE ANTENNA ALARM BEEPED AND THE CYCLE STOPPED. CONNECTED A NEW BAG AND FINISHED OUT THE ABLATION. WHEN SMOOTHLY REMOVING THE NEEDLE AT PROCEDURE END, THERE WAS NO TIP AND FLUID WAS DRIPPING FROM THE TIP. COMPUTED TOMOGRAPHY, WHICH WAS PART OF THE PROCEDURE, WAS PERFORMED TO LOCATE THE RETAINED NEEDLE TIP AND IT WAS FOUND IN THE DEEP MARGIN OF THE TUMOR. A LARGE AMOUNT OF FLUID WAS OBSERVED AROUND THE KIDNEY AS WELL. ALTHOUGH TWO LESIONS WERE INITIALLY PLANNED FOR ABLATION, THE SURGEON CHOSE TO ABORT THE PROCEDURE AFTER THE INCIDENT DUE TO THE SIGNIFICANT FLUID ACCUMULATION. THE TREATMENT FOR SECOND LESION WAS RESCHEDULED. THE PATIENT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 22393063 ↗
• MalfunctionJun 23, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING ABLATION, THE DEVICE FAILED TO CIRCULATE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307871 ↗
• MalfunctionJun 23, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE FAILED TO CIRCULATE. THE PROBE WAS FOUND TO BE FAULTY AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307819 ↗
• MalfunctionMay 1, 2025Failure to Fire; No Flow; Failure to Fire; No Flow

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE DID NOT ABLATE, AND AIR WAS REPORTED IN THE IRRIGATION TUBING. ANOTHER DEVICE USED SUCCESSFULLY WITH THE SAME GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943796 ↗
• MalfunctionMay 1, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE FAILED TO CIRCULATE. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943212 ↗
• InjuryApr 18, 2025Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PROCEDURE, 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. DUE TO THE INCIDENT, THE PROCEDURE WAS HALTED MOMENTARILY TO REPLACED THE DEFECTIVE DEVICE AND IT WORKED FINE.

  Patient problems: Insufficient Information

  MAUDE report 21867529 ↗
• InjuryApr 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE CATHETER FELL OFF IN THE PATIENT AFTER ABLATION WHILE REMOVING THE DEVICE. THEY USED THE CT SCANNER TO LOCATE THE TIP AND IT WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED, INVOLVING A SINGLE LESION LOCATED IN SEGMENT TWO, MEASURING 1.5 CM, WITH STRAIGHTFORWARD INSERTION INTO A FAIRLY SUPERFICIAL, VISIBLE LESION. NO ADDITIONAL PROCEDURE WAS NEEDED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21753613 ↗
• InjuryApr 2, 2025Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LIVER ABLATION PROCEDURE, A TEMPERATURE ALARM APPEARED ON THE MAIN SCREEN. THE PATIENT, WHO HAD A MEDICAL HISTORY OF LIVER CYSTS, WAS ALREADY UNDER SEDATION WITH THE ANTENNA POSITIONED ON THE LIVER. DUE TO THE EQUIPMENT MALFUNCTION, THE PHYSICIAN DECIDED TO REMOVE THE ANTENNA AND CANCEL THE PROCEDURE. PROCEDURE WAS RE-SCHEDULE FOR (B)(6) 2025. BIOMED PERFORMED SOME TECHNICAL EVALUATION OF THE GENERATOR AND NO NEGATIVE ISSUES FOUND. THE SURGEON ALSO USED A NEW ANTENNA WITH THE SAME GENERATOR, AND IT WORKED WELL.

  Patient problems: Insufficient Information

  MAUDE report 21753584 ↗
• MalfunctionFeb 18, 2025Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING ABLATION, THE TUBING BROKE AND WATER LEAKED, LEADING TO THE INABILITY TO PERFORM THE PROCEDURE, WHICH WAS SUBSEQUENTLY ABORTED. THE PATIENT WAS UNDER ANESTHESIA AT THE TIME, AND THE PROCEDURE WAS CANCELLED. THE ANTENNA WAS PLACED IN THE PATIENT, BUT UPON BEGINNING THE ABLATION, THE SYSTEM GAVE AN ERROR.

  Patient problems: Insufficient Information

  MAUDE report 21401406 ↗
• MalfunctionNov 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, TWO SESSIONS OF ABLATION WERE PERFORMED AT 45W FOR 1 MINUTE AND 75W FOR 2 MINUTES. A TRANSPARENT OBJECT (COATING) WAS HANGING DOWN, AND WAS REMOVED. IT STARTED TO PEEL OFF, SO IT WAS COMPLETELY PEELED OFF BY HAND AND WAS NOT USED AFTER PEELING IT OFF. WHEN CHECKING THE USE OF THE NEEDLE GUIDE, IT WAS FOUND TO HAVE BEEN USED BECAUSE A BIOPSY WAS PERFORMED BEFORE THE ABLATION. IT WAS SAID THAT IT HAD BEEN INSERTED AND REMOVED 2 OR 3 TIMES DURING THE ABLATION APPROACH, WHICH WAS THOUGHT TO BE THE CAUSE. A NEW ANTENNA WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612650 ↗
• MalfunctionOct 19, 2024Leak/Splash; No Flow; Appropriate Device Problem Term/Code Not Available; Leak/Splash; No Flow; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, AIR BUBBLES CIRCULATING IN THE COOLING LINE, WHICH CAUSED THE GENERATOR TO OVERHEAT AND STOP PROCESSING AFTER ONE MINUTE. PROCEDURE INCOMPLETE, FAILED TREATMENT WAS NOT CONTINUED. PATIENT TO BE RECONVENED. PATIENT UNDER ANESTHESIA WHEN THE ISSUE OCCURRED. ANOTHER ANTENNA HAS BEEN USED SUCCESSFULLY WITH THE SAME GENERATOR.

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

  MAUDE report 20489081 ↗
• InjuryOct 4, 2024Appropriate Device Problem Term/Code Not Available; 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 20376164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163105. One submission often covers many models, so check the product and lot details in each record.

• Z-0627-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of sof
• Z-0626-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation)
• Z-0625-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) o