EmprintRecalls & reported problems across all models

We found 19 models of Emprint by Covidien LP in the FDA's device registry (GUDID). Together they are named in 405 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2016 and Sep 23, 2026 — classified as 10 deaths, 181 injuries, 214 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (77 reports).

9 FDA recall records name at least one of these models by its device identifier, 9 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Emprint recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 15, 2018Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0627-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Nov 15, 2018Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0626-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Nov 15, 2018Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0625-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Aug 7, 2017Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0561-2018 · Root cause: Device Design · Recall details · FDA record ↗

5. Aug 7, 2017Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0560-2018 · Root cause: Device Design · Recall details · FDA record ↗

6. Aug 7, 2017Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0559-2018 · Root cause: Device Design · Recall details · FDA record ↗

7. Aug 7, 2017Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0558-2018 · Root cause: Device Design · Recall details · FDA record ↗

8. Aug 7, 2017Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0557-2018 · Root cause: Device Design · Recall details · FDA record ↗

9. Aug 7, 2017Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0556-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Emprint problems

Emprint models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Emprint CA20L2

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  2 recalls1 death43 reports
• Emprint CA15L2

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  2 recalls1 death41 reports
• Emprint CA30L2

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  2 recalls2 reports
• Emprint CA15L1

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  1 recall49 reports
• Emprint CA20L1

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  1 recall18 reports
• Emprint CA15L2

  Electrosurgical, cutting & coagulation & accessories
  1 death66 reports
• Emprint CA30L1

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  1 recall1 death9 reports
• Emprint CAGEN1

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  2 deaths53 reports
• Emprint CA20L2

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  2 deaths52 reports
• Emprint CA190RC1

  ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
  1 death16 reports
• Emprint CA20L1

  Electrosurgical, cutting & coagulation & accessories
  13 reports
• Emprint CA30L2

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  12 reports
• Emprint CAPUMP1

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  1 death10 reports
• Emprint CA15L1

  Electrosurgical, cutting & coagulation & accessories
  5 reports
• Emprint CAGEN1ZD

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  4 reports
• Emprint CA20L1

  Electrosurgical, cutting & coagulation & accessories
  4 reports
• Emprint CA15L1

  Electrosurgical, cutting & coagulation & accessories
  3 reports
• Emprint CA30L1

  SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
  3 reports
• Emprint CA30L1

  Electrosurgical, cutting & coagulation & accessories
  2 reports

Recent Emprint adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryAug 6, 2026Device Alarm System; Adverse Event Without Identified Device or Use Problem

  It was reported that during an ablation procedure, the error code ¿antenna temperature limit exceeded¿ was displayed and recurred. The antenna was not used extensively, but it showed this error during two prior ablations, one time with 150W for 10 minutes. One time with 150W for 7 minutes. It was reported that the cooling saline had been cooled in a refrigerator, the pump was running, and the cooling saline did not heat up and the procedure was followed as instructed. It was reported that after several resets, the ablation could be finished with a positive result; however, the error occurred again in retract mode, but the track ablation was nearly finished, therefore, the surgeon saw the ablation as completed. The generator worked well with a new antenna.

  Patient problems: Insufficient Information

  MAUDE report 50159490 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 2, 2026Overheating of Device; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT WITH CIRRHOSIS, HEPATOCELLULAR CARCINOMA WAS TREATED WITH MICROWAVE ABLATION FOR A LIVER TUMOR. AN UNINTENDED TISSUE DAMAGE WAS OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT, AND THERE WAS NO DELAY IN OVERALL PROCEDURE TIME OR NEED FOR ADDITIONAL TREATMENT OR SURGERY. NO ERROR OR MESSAGES OCCURRED DURING PROCEDURE. SETTING WERE 150 WATTS FOR 2:30 MINUTES FOR A 3.5 X 4.1 CM ABLATION. HOWEVER, ON POST OPERATIVE DAY 1 CT (COMPUTED TOMOGRAPHY) SCAN, THE ABLATION CAVITY WAS UP TO 5.9 CENTIMETER IN DIAMETER, WELL ABOVE THE PREDICTED ABLATION DIAMETER OF 4.1 CENTIMETER. CT IMAGING ARGUE FOR SOME HEPATIC STEATOSIS, IN ADDITION TO CIRRHOSIS.

  Patient problems: Tissue Breakdown

  MAUDE report 24233752 ↗
• InjuryJan 28, 2026Difficult or Delayed Activation; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE FAILED TO DELIVER POWER. THE ENERGY COULD NOT REACH THE LESION. RESTARTED THE EQUIPMENT, REPLACED THE POWER CORD, AND REMOVED/DISCONNECTED THE ANTENNA CABLE. DESPITE THESE INTERVENTIONS, WHEN ATTEMPTING TO PERFORM A SUPERFICIAL ABLATION, IT WAS FOUND THAT NO POWER WAS BEING DELIVERED TO THE TISSUE, MAKING IT IMPOSSIBLE TO CONTINUE THE PROCEDURE WITH THIS SYSTEM. THE PROCEDURE CONTINUED WITHOUT THE USE OF TECHNOLOGY. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24198893 ↗
• 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 ↗

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