Emprint CA15L2 (UDI 10884521706583)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10884521706583), received between Oct 25, 2017 and Oct 18, 2023 — classified as 1 death, 29 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 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.

Recalls naming this device

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

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE AND WHEN PHYSICIAN REALIZED DURING POST-OPERATION CONTROL IMAGING, IMPORTANT DIFFERENCE BETWEEN ABLATION CHART AND CLINICAL RESULT: 100WATTS DURING 10 MINUTES, ONLY PROVIDE A 28MM LONG ABLATION (ON THE LONG AXIS). ANTENNA HAS NOT BEEN ABLE TO MAKE A COMPLETE ABLATION, AS THE PHYSICIAN NOTED THE SPHERE WAS NOT GROWING ON THE FULL LENGTH OF THE RADIATING AREA OF THE ANTENNA (REMAINING ON THE FRONT ZONE). THE PATIENT HAD TUMORAL LESION RELAPSE. IN OTHER WORD, A LESION GREW BECAUSE OF UNTREATED REMAINING CANCER CELLS IN THE PREDICTED AREA OF TREATMENT, APPEARED AT THE LIMIT OF THE PREVIOUS TREATMENT AREA. THE TUMOR DID NOT GO BACK TO ITS ORIGINAL SIZE, BUT A SECOND ONE GREW ON THE PERIPHERAL ZONE OF ABLATION, WHERE ABLATION CHARTS INDICATED IT HAD BEEN TREATED. THIS CAUSED FOR A SECOND OPERATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO OTHER INJURIES ON THE PATIENT.

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

  MAUDE report 17961900 ↗
• MalfunctionMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABLATION, THE PATIENT HAD THERMAL BURN ON THE PERITONEUM AFTER 10 MINUTES USE ON 150 WATTS.

  Patient problems: Burn(s)

  MAUDE report 16942661 ↗
• MalfunctionDec 9, 2021Device 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 ABLATION PROCEDURE, THE TEMPERATURE SIGN WAS ON AFTER 2 MINUTES OF ABLATING, AT 100WATTS. PRESSING RESET BUTTON DID NOT ALLOW THE PHYSICIAN TO RESUME HIS PROCEDURE. THEY TURN OFF THE GENERATOR AND LET IT COOL DOWN FOR 10MINUTES. BUT AFTER TURNING ON AGAIN THE GENERATOR, TEMPERATURE ALARM TURNED ON AGAIN AFTER A FEW SECOND OF ABLATING. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12967453 ↗
• InjuryJan 11, 2021Device Alarm System; Intermittent Energy Output; Device Alarm System; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD HIGH TEMPERATURE ALARM AND STOPPED WORKING. AFTER REPLACING THE ANTENNA WITH NEW ONE, THE PROCEDURE COMPLETED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11144967 ↗
• InjuryNov 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A KIDNEY ABLATION, AT THE END OF THE FIRST CYCLE THEY CHANGED THE POSITION OF THE ANTENNA AND PERFORMED ANOTHER ABLATION. EACH ABLATION WAS FOR 3 MINUTES AT 100 WATTS. A NEEDLE GUIDE WAS NOT USE. AFTER THE SECOND CYCLE, THEY FINISHED THE TREATMENT AND PERFORMED A CT (COMPUTED TOMOGRAPHY) SCAN AND ONLY THEN NOTICED THAT THERE WAS A LOT OF BLOOD IN THE ANTENNA TUBE. THEY SAW THAT THE TROCAR TIP OF THE ANTENNA HAD COME OFF. THERE WAS NO UNUSUAL FORCE USED ON THE EVENT. THE TIP REMAINS INSIDE THE TUMOR IN THE KIDNEY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. A PICTURE WAS SUBMITTED WHICH SHOWED THE BROKEN ANTENNA WITHOUT ITS TIP.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 10796320 ↗
• InjuryNov 5, 2020Device 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, AFTER PLACING THE ANTENNA INSIDE THE TUMOR, IT TRIED TO OPERATE BUT THE GENERATOR DID NOT WORK WHEN TWO ALARMS WERE LIT (TEMPERATURE AND PEDAL), ALTHOUGH THE GENERATOR WAS NOT CONNECTED TO THE PEDAL. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THEY CONNECTED THE ANTENNA THAT WORKED WITH THE FIRST PROCEDURE AND SAW THAT IT DID WORK IN CONTRAST TO THE NEW ANTENNA. SINCE THEY HAD NO ADDITIONAL ANTENNA, THEY HAD TO STOP THE PROCEDURE AND BECAUSE THE PATIENT WAS UNDER ANESTHESIA, THEY HAD TO WAKE THE PATIENT WITHOUT PERFORMING AN ABLATION. THE PATIENT WAS DISCHARGED HOME.

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

  MAUDE report 10791868 ↗
• InjuryAug 10, 2020Device 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 LIVER ABLATION, THE ANTENNA HAD TEMPERATURE ERROR WHEN THEY TRIED TO USE IT. THEY RESET THE GENERATOR AND RESTARTED BUT ERROR PERSISTED. ANOTHER ANTENNA WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DISMISSED FROM HOSPITAL ON (B)(6) 2020. THEY WENT TO THE ER (EMERGENCY ROOM) ON (B)(6) 2020 WITH ABDOMINAL PAIN AND SUBCUTANEOUS HEMATOMA BUT NO ACTIVE BLEEDING WAS SHOWN ON CT (COMPUTED TOMOGRAPHY) AND WAS DISMISSED FROM EMERGENCY ROOM ON (B)(6) 2020. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Abdominal Pain; Hematoma

  MAUDE report 10385984 ↗
• InjuryJun 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABLATION, THE CERAMIC TIP OF THE ANTENNA WAS DETACHED AFTER SEVERAL ABLATION. THE DETACHED PART REMAINED IN PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10167626 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER ABLATION, THE RADIOLOGIST SPOTTED EMBOLISM IN THE PATIENT'S AORTA AND RIGHT ATRIUM AND ALSO HAD PNEUMOTHORAX ON THE RIGHT LUNG SIDE.

  Patient problems: Embolism; Pneumothorax

  MAUDE report 10166567 ↗
• InjuryMay 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LIVER ABLATION WITH EMPRINT SYSTEM, THE DOCTOR INITIALLY PERFORMED A 7.5 MINUTE ABLATION AT 75W. WITH THE ZONE THE DOCTOR WAS SEEING WITH ULTRASOUND, THEY PERFORMED ANOTHER ABLATION WITHOUT MOVING THE ANTENNA OF 2 MINUTES AT 100 WATTS. THE DOCTOR DID A POST-PROCEDURAL CONTRAST CT (COMPUTED TOMOGRAPHY). THE MEASUREMENTS WERE 30.44MM X 18.56MM. THE RADIOLOGY TECHNICIAN FORGOT TO START THE PUMP WHEN THE ABLATION (75W X 7.5 MINUTES) STARTED. THEY GOT AN ALARM, RESET THE DEVICE, STARTED THE PUMP AND RESTARTED THE ABLATION. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE.

  Patient problems: Radiation Exposure, Unintended

  MAUDE report 10050563 ↗
• InjuryMay 6, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  THE DEVICE WAS RETURNED WITHOUT A COMPLAINT INFORMATION.

  Patient problems: No Information

  MAUDE report 10029862 ↗
• InjuryMay 6, 2020Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, THE DEVICE WAS RETURNED WITHOUT A COMPLAINT INFORMATION. INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CERAMIC TIP IS MISSING FROM THE DEVICE. THE TIP WAS NOT RETURNED.

  Patient problems: No Information

  MAUDE report 10029723 ↗
• InjuryMar 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, ABLATION OF CHONDROBLASTOMA, THE ANTENNA BROKE OFF IN PATIENT AFTER TWO REPOSITIONING WITHIN THE LESION. THERE WAS NO RESISTANCE EXPERIENCE WITHIN THE LESION. IMAGING WAS DONE TO LOCATE THE TIP OF THE ANTENNA AND IT WAS FOUND IN THE LESION.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 9877283 ↗
• InjuryFeb 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE WAS RETURNED WITHOUT ANY ACCOMPANYING COMPLAINT INFORMATION.

  Patient problems: No Information

  MAUDE report 9741541 ↗
• InjuryFeb 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ABLATION FOR METASTATIC WILM¿S DISEASE, THE CERAMIC TIP FELL OFF WHILE REMOVING THE ANTENNA FROM THE PATIENT. THE TIP REMAINED INSIDE THE PATIENT. NO SURGERY DONE TO REMOVE THE TIP. THE DOCTOR WAS PLANNING TO DO AN MRI ON THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9678369 ↗
• InjuryJan 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABLATION, THE ANTENNA WAS COMPLETELY REINSERTED A TOTAL OF TWO TIMES, REPOSITIONED TWICE PER INSERTION, AND ONE ADDITIONAL MINOR ADJUSTMENT BUT THE TIP OF THE PROBE BROKE WHILE IN THE PATIENT BODY AFTER PROVIDING 5 ABLATIONS. THE PHYSICIAN HAD DECIDED TO LEAVE THE TIP IN THE PATIENT BODY WITH PATIENT'S CONSENT. COMPUTED TOMOGRAPHY (CT) SCAN LOCATED THE TIP WITHIN THE LIVER.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 9558482 ↗
• DeathSep 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A CASE USING ABLATION, THE PATIENT IN RECOVERY GOT UP FROM THEIR BED, FELL AND HAD AN EMBOLISM THAT RESULTED IN THE DEATH OF THE PATIENT. IN THIS CASE A 15CM ANTENNA WAS USED AT 75 WATTS FOR 4 MINUTES. THE TECHNICIAN DID NOT BELIEVE THE EMBOLISM WAS RELATED TO THE COMPLICATIONS. THERE WERE NO DEVICE DEFICIENCY NOTED.

  Patient problems: Death; Embolism

  MAUDE report 8998267 ↗
• InjuryMay 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AFTER A TRACK ABLATION WAS DONE AFTER ABLATION OF THE 2ND LESION BUT BEFORE THE PHYSICIAN WANTED TO REINSERT THE MICROWAVE ANTENNA FOR ABLATION OF THE 3RD LESION, IT WAS OBSERVED THAT THE TROCAR WHITE TIP WAS NO LONGER ON THE ANTENNA. COMPUTED TOMOGRAPHY (CT) SCAN WAS CARRIED OUT AND TROCAR WHITE TIP WAS OBSERVED TO BE IN THE PATIENT BODY, AT THE LOCATION OF THE ABLATION ZONE. ANOTHER DEVICE WAS OPEN TO COMPLETE THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8653640 ↗
• InjuryMay 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A TRACK ABLATION OF A SECOND LESION EXOPHYTIC TUMOR, SITUATED IN SEGMENT 2 IN A CRITICAL LOCATION WHICH TOOK 15 MINUTES TO COMPLETE, THE ANTENNA GOT STUCK SOMEHOW HALF WAY AND THEN WHILE PULLING IT BACK WITH SOME FORCE, THEY SAW THE DEVICE COME OUT WITHOUT THE CERAMIC TIP. THE PROCEDURE WAS ABLE TO BE COMPLETED BY THE INCIDENT DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8638664 ↗
• InjuryMay 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABLATION, THE ANTENNA WAS ABLE TO ABLATE TISSUE. BUT WHEN PHYSICIAN MOVED IT BACK THE CERAMIC TIP LEFT IN PLACE(REMAINED IN THE LIVER) AND DISASSEMBLED AND REMAINED IN THE LIVER. TIP COULD NOT BE REMOVED. WITH SECOND ANTENNA ALL STEPS WERE PERFORMED INCLUSIVELY TRACK ABLATION. CT SCAN WAS PERFORMED FOR THE CERAMIC TIP THAT HAS LEFT IN THE LIVER ON AN UNPROBLEMATIC POSITION WHICH FROM OF PHYSICIANS DECIDED DID NOT REQUIRE RESECTION. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8596950 ↗
• InjuryApr 16, 2019Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING MICROWAVE ABLATION OF LIVER, THE TIP OF THE PROBE STAYED INSIDE OF THE LIVER AFTER TWO 10 MINUTES OF ABLATION WHICH IT CHARRED ITSELF INTO POSITION AND WHEN IT WAS TAKEN OUT, THERE WAS SALINE SOLUTION COMING OUT OF AN OPEN TIP. CT SCAN WAS DONE.

  Patient problems: Device Embedded In Tissue or Plaque; Radiation Exposure, Unintended

  MAUDE report 8521061 ↗
• InjuryJan 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LIVER ABLATION, THEY FIRST DISCOVERED THAT THE TIP WAS BROKEN WHEN THEY PULLED OUT THE ANTENNA, THERE WAS NO ERROR MESSAGE ON THE DISPLAY DURING THE PROCEDURE, AND THE TIP OF THE ANTENNA REMAINED INSIDE THE LIVER IN THE FOURTH LESION. PATIENT IS FEELING WELL WITH NO COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 8276665 ↗
• InjuryNov 19, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, CERAMIC TIP BROKE OFF IN PATIENT AS LEAD COMPUTERIZED TOMOGRAPHY (CT) TECH NOTICED ON SCAN AND IMMEDIATELY NOTIFIED THE PHYSICIAN. THE PHYSICIAN PROCEEDED TO OPEN ANOTHER ANTENNA AND PROCEEDED HAMMERING THE ANTENNA AGAIN TO DESIRED LOCATION. A NEW DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8087430 ↗
• InjuryNov 8, 2018Overheating of Device; Overheating of Device

  ACCORDING TO THE REPORTER, AFTER THE WITHAFERIN A (WFA) FOR LIVER CANCER, THE ACTIVATION WAS COMPLETED AND THE BLUE CABLE EXTENDING FROM THE ANTENNA WAS QUITE HOT. THE DOCTOR FELT THAT IT COULD CAUSE BURN INJURY IF IT CONTACTED A PATIENT FOR A LONG TIME. THE ACTIVATION WAS "45W FOR 1 MINUTE, 55W FOR 1 MINUTE, 65W FOR 1 MINUTE, 75W FOR 1 MINUTE, 100W FOR 5 MINUTES". POST-OPERATIVELY, THE PATIENT RECEIVED 4 UNITS OF BLOOD TRANSFUSION. IT WAS NOTED THAT THE PATIENT HAD A BLOOD PLATELET OF BELOW 50,000 AND HEMOGLOBIN DROPPED TO 4. A 10KG OF ASCITIC FLUID WAS POOLED, AND IT WAS DRAINED. PATIENT'S CONDITION WAS CURRENTLY FINE.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 8051332 ↗
• InjuryOct 22, 2018Connection Problem; Temperature Problem; Connection Problem; Temperature Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS USED FOR LUNG MALIGNANT TUMOR. ACTIVATION WAS STARTED WITH ANTENNA, BUT TEMPERATURE ERROR OCCURRED IMMEDIATELY AFTER THE ACTIVATION STARTED. THE SALINE WAS CHECKED, AND IT WAS AT ROOM TEMPERATURE. TO SPECIFY WHICH ONE OF THE ANTENNAS AND THE GENERATOR WAS THE CAUSE, A NEW ANTENNA WAS USED, AND ITS ACTIVATION WAS CHECKED, AND IT COULD BE ACTIVATED WITHOUT PROBLEM. AFTER THAT, A NEW ANTENNA WAS USED, AND THIS TIME THE ERROR "ANTENNA NOT DETECTED" OCCURRED SIMULTANEOUSLY WHEN POWERING ON. CONNECTED THE FIRST ANTENNA FOR A TRIAL, AND THE ERROR "ANTENNA NOT DETECTED" ALSO OCCURRED. BECAUSE THE GENERATOR WAS NOT STABLE, RF ABLATION WAS DECIDED TO BE PERFORMED ACCORDING TO THE DOCTOR'S JUDGMENT. THE TUMOR SEEMED TO BE ABLATED, BUT COMPLICATIONS (HEMOTHORAX) OCCURRED AND AT PRESENT THE PATIENT WAS UNDER OBSERVATION. THE SURGICAL TIME WAS EXTENDED, AND REOPERATION WAS REQUIRE D DUE TO THE ISSUE.

  Patient problems: Hemothorax; No Code Available

  MAUDE report 7990020 ↗

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-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
• 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