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Emprint CA20L2 (UDI 10884521706590)Recalls & reported problems

Covidien LP · Standard Percutaneous Antenna with Thermosphere (TM) Technology Large Spherical Ablation Zone - Reinforced Antenna · Class 2

All models of Emprint (19)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This Covidien Emprint microwave ablation antenna is a needle used to destroy liver lesions by heating tissue. The 43 reports mostly describe the ceramic tip breaking off or coming loose during or after ablation, sometimes leaving a fragment in the liver, along with irrigation tubing that bent and generators giving temperature alarms. Reports include 1 death and 25 injuries. Two open recalls, started in August 2017 and November 2018, concern the ceramic trocar tip disengaging from the needle shaft so the tip can remain in the patient.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
43
Deaths reported
1
Injuries reported
25
Recalls naming it
2

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10884521706590), received between Aug 4, 2017 and Oct 16, 2024 — classified as 1 death, 25 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (25 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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-0627-2019 · Root cause: Nonconforming Material/Component · Recall details · 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-0559-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Detachment of Device or Device Component25
  • Adverse Event Without Identified Device or Use Problem9
  • Break4
  • No Flow4
  • Peeled/Delaminated3
  • Device Alarm System2
  • Electrical Shorting2
  • Leak/Splash2

Patient problems

  • Device Embedded In Tissue or Plaque14
  • No Consequences Or Impact To Patient10
  • No Code Available6
  • Radiation Exposure, Unintended6
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
  • Foreign Body In Patient4
  • No Information3
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, POST OPERATIVE ABLATION, SEVERE POPPING OCCURRED AT 75 WATTS 2 MINUTES AND 50 SECONDS AFTER EMPRINT OUTPUT BEGAN. THERE WAS A RISK OF RUPTURE, BUT THERE WAS NO CHANGE IN BLOOD PRESSURE, NO BLEEDING SYMPTOMS, AND THE PATIENT DID NOT APPEAR TO COMPLAIN OF PAIN, SO THE PROCEDURE CONTINUED. THE PROCEDURE WAS COMPLETED AND THE ABLATION WAS COMPLETED AS EXPECTED, AND A POS T-OPERATIVE CT SCAN TAKEN THE SAME DAY SHOWED THAT THE ABLATION HAD BEEN COMPLETED WITHOUT ANY PROBLEMS. AT AROUND 18:00 THE SAME DAY, THE DOCTOR IN CHARGE CONFIRMED THAT ASCITES WAS LEAKING, AND A BLOOD CLOT APPROXIMATELY 3CM IN SIZE WAS CONFIRMED ON THE IMAGES. IT WAS SAID THAT IT WAS NOT A LIFE-THREATENING COMPLICATION, AND THE PATIENT WAS CURRENTLY UNDER OBSERVATION. THERE WERE NO SEVERE COMPLICATIONS THAT LED TO DEATH. THE HOSPITAL PROTOCOL WAS FOLLOWED: 45W FOR 1 MINUTE, 60W FOR 1 MINUTE, 75W FOR 1 MINUTE, AND 100W FOR 10 MINUTES. THE TUMOR WAS HCC (HEPATOCELLULAR CARCINOMA), THE INSIDE OF THE TUMOR WAS SOFTER THAN USUAL (THE ANTENNAE WERE MORE LIKELY TO MOVE INSIDE THE TUMOR), AND BUBBLES DURING CAUTERIZATION DID NOT APPEAR UNTIL POPPING OCCURRED (BUBBLES USUALLY OCCUR BETWEEN THE LATT

    Patient problems: Ascites

    MAUDE report 20461921 ↗
  • MalfunctionSep 1, 2021Material Twisted/Bent; No Flow; Material Twisted/Bent; No Flow

    ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, WHEN CIRCULATING THE IRRIGATION WATER, THE TUBE NEAR THE SPIKE WAS FOUND TO BE BENT AND COULD NOT CIRCULATE WELL. THE PROCEDURE WAS COMPLETED WITH THE DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12410796 ↗
  • MalfunctionJul 19, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BROKE DURING TO USE ON PATIENT. THE BROKEN PIECE FALL INTO THE PATIENT CAVITY BUT WAS ABLE TO REMOVE/RETRIEVE. THE PROCEDURE WAS COMPLETED WITH THE NEW DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12193922 ↗
  • InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING THE ABLATION, THE GASTRIC WALL WAS DAMAGED AS A RESULT OF ABLATION OF THE LESION OUTSIDE OF THE TARGET LESION FOR TREATMENT. IT WAS MENTIONED THAT IT WAS A PROCEDURE ERROR DONE BY THE PHYSICIAN.

    Patient problems: Unspecified Tissue Injury

    MAUDE report 12012443 ↗
  • InjuryMay 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE ANTENNA TIP (4 MM) WAS LEFT IN THE PATIENT'S LIVER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 11778380 ↗
  • InjuryFeb 11, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING AN ABLATION, THE DEVICE'S TIP DISCONNECTED AND WAS LEFT IN PATIENT'S LIVER. PROCEDURE DID THREE TIMES 10 MINS 100W AFTER LAST ABLATION WHEN NEEDLE WAS OUT. IT WAS FOUND OUT THAT WATER CAME OUT FROM THE TIP. UPON CHECKING, THE TIP (WHITE PART) WAS LEFT IN THE LIVER.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 11313139 ↗
  • InjuryDec 30, 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 AN ABLATION PROCEDURE, THE CATHETER WAS PLACED IN THE CORRECT POSITION (IN THE LIVER) BY THE PHYSICIAN, THE GENERATOR WAS ON THE CATHETER CONNECTED, THE WATTAGE WAS SET TO 80, AND THE TIME WAS SET TO FOUR MINUTES. THE NURSE PRESSED THE START BUTTON BUT THE GENERATOR FAILED TO ACTIVATE AND IT WAS GIVING THE GENERAL WARNING CODE. THEY PRESSED THE RESTART BUTTON, AND REPEATED THE PROCESS TWICE BUT STILL NOTHING HAPPENED. THEY WAITED A FEW MORE MINUTES AND REPEATED THE PROCESS ONE MORE TIME, THEN CHECKED THE TUBING, THE CONNECTIONS, AND RESTARTED THE PROCEDURE AT THE SAME 80 WATTS AND FOUR MINUTES BUT STILL NOTHING HAPPENED. AFTER CONSULTING THE MANUAL, THE PHYSICIAN DECIDED TO WAIT SIX MINUTES AND AGAIN RESTARTED THE PROCEDURE AND STILL NOTHING HAPPENED. THE GENERAL WARNING ALARM OCCURRED ON EACH ATTEMPT. THE ALARM WAS ACTIVATED WHEN THEY PRESSED THE ¿START/STOP¿ BUTTON ON THE G ENERATOR. THE CATHETER DID NOT ACTIVATE, IT NEVER STARTED AT ALL. AFTER A FEW MORE ATTEMPTS THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE WITHTHE PATIENT STILL UNDER ANESTHESIA.

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

    MAUDE report 11094941 ↗
  • InjuryDec 29, 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 AN ABLATION PROCEDURE, THE GENERATOR STOPPED ABLATING AND SHOWED TEMPERATURE ERRORS FOR ANTENNA TEMPERATURE LIMIT EXCEEDED AND THEN IT WAS FOLLOWED BY A RED EXCLAMATION ALARM WHICH WAS A GENERAL WARNING ERROR. THEY COULD NOT RESUME WITH THE ABLATION AND THE PROCEDURE WAS CANCELLED WHILE PATIENT WAS UNDER ANESTHESIA.

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

    MAUDE report 11088905 ↗
  • MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A MICROWAVE ABLATION, THE SURGEON TRIED TO PUSH THE ANTENNA IN THE HOLE OF THE ULTRASOUND PROBE AND THE ANTENNA COULD GO THROUGH AND IT BROKE. A PART OF THE DEVICE WAS COMPLETELY DISENGAGED BUT NOTHING FELL INTO THE PATIENT'S CAVITY. IT WAS RETRIEVED IN THE ULTRASOUND (US) PROBE WITHOUT ANY PROBLEM AND INTERVENTIONS WERE MADE TO VERIFY THAT NO PARTS LEFT IN THE PATIENT'S CAVITY. THE SURGEON TRIED WITH A SECOND ANTENNA AND IT WAS THE SAME THEN TRIED A THIRD ANTENNA AND STILL THE SAME. THE SURGEON USED A FOURTH ANTENNA AND THAT COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10713715 ↗
  • MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A MICROWAVE ABLATION, THE SURGEON TRIED TO PUSH THE ANTENNA IN THE HOLE OF THE ULTRASOUND PROBE, AND THE ANTENNA COULD GO THROUGH AND IT BROKE. A PART OF THE DEVICE WAS COMPLETELY DISENGAGED, BUT NOTHING FELL INTO THE PATIENT'S CAVITY. IT WAS RETRIEVED IN THE ULTRASOUND (US) PROBE WITHOUT ANY PROBLEM, AND INTERVENTIONS WERE MADE TO VERIFY THAT NO PARTS LEFT IN THE PATIENT'S CAVITY. THE SURGEON TRIED WITH A SECOND ANTENNA, AND IT WAS THE SAME THEN TRIED A THIRD ANTENNA, AND STILL THE SAME. THE SURGEON USED A FOURTH ANTENNA, AND THAT COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10713555 ↗
  • MalfunctionOct 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A MICROWAVE ABLATION, THE SURGEON TRIED TO PUSH THE ANTENNA IN THE HOLE OF THE ULTRASOUND PROBE AND THE ANTENNA COULD GO THROUGH AND IT BROKE. A PART OF THE DEVICE WAS COMPLETELY DISENGAGED BUT NOTHING FELL INTO THE PATIENT'S CAVITY. IT WAS RETRIEVED IN THE ULTRASOUND (US) PROBE WITHOUT ANY PROBLEM AND INTERVENTIONS WERE MADE TO VERIFY THAT NO PARTS LEFT IN THE PATIENT'S CAVITY. THE SURGEON TRIED WITH A SECOND ANTENNA AND IT WAS THE SAME THEN TRIED A THIRD ANTENNA AND STILL THE SAME. THE SURGEON USED A FOURTH ANTENNA AND THAT COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10713484 ↗
  • InjuryOct 12, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BROKE DURING USE ON PATIENT. THE DEVICE DID NOT COMPLETELY DISENGAGED SO NOTHING FELL INTO THE PATIENT'S CAVITY. THE PATIENT WAS UNDER ANESTHESIA WHEN THE PROCEDURE WAS ABORTED AND IT WOULD BE RESCHEDULED.

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

    MAUDE report 10666878 ↗
  • InjurySep 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE WHICH WAS PERFORMED FOR A TOTAL OF 6 TIMES FOR 3 LIVER TUMORS, AFTER THE 6TH ABLATION WAS COMPLETED, THE DEVICE WAS REMOVED WHILE PERFORMING TRACT ABLATION. IT WAS FOUND THAT THE CERAMIC PART AT THE TIP WAS CHIPPED BECAUSE SALINE WAS SPOUTING FROM THE TIP. COMPUTED TOMOGRAPHY (CT) IMAGING REVEALED REMAINING PART IN THE LIVER.

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

    MAUDE report 10609693 ↗
  • InjurySep 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS DETACHED WHEN IT WAS PULLED OUT OF THE PATIENT AND THE PROCEDURE HAS NOT BEEN COMPLETED. THE PATIENT WAS UNDER ANESTHESIA WHEN THE PROCEDURE WAS CANCELLED.

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

    MAUDE report 10531785 ↗
  • InjuryAug 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING PERCUTANEOUS LIVER TUMOR ABLATION, THE TIP OF A 20CM ANTENNA BROKE OFF (PORTION AFTER THE GREEN SECTION) AFTER THE DOCTOR WAS REPOSITIONING THE ANTENNA FOR A 5TH ABLATION OF LARGE LIVER TUMOR. SUBSEQUENTLY, THE DOCTOR REMOVED THE ANTENNA AND INSERTED A NEW 20CM PROBE TO RESUME THE CASE. IT WAS NOTED THAT THERE WAS NO LATERAL FORCE APPLIED TO ANTENNA. THE DOCTOR WAS HANDLING THE PROBE FRAGMENT LOCATED IN THE LIVER AS IF IT WAS A SURGICAL CLIP AND WAS NOT SEEKING TO REMOVE IT. THE PROCEDURE PRECEDED WITH ANOTHER ANTENNA TO COMPLETE THE CASE.

    Patient problems: Foreign Body In Patient

    MAUDE report 10407540 ↗
  • InjuryAug 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING A PERCUTANEOUS ABLATION PROCEDURE, SINCE THE LESION WAS RELATIVELY LARGE (27 X 28MM), 3 SUCCESSIVE ABLATIONS (EACH WITH 100W/10 MINUTES) WITH COMPLETE ANTENNA REMOVAL AND RE-INSERTIONS AFTER EACH ABLATION CYCLES WERE PLANNED. THE CASE WAS DONE WITH A CAS-ONE STEREOTACTIC NAVIGATION SYSTEM FROM CASCINATION. THERE WAS ADHERENCE TO RECENT IFU (INSTRUCTIONS FOR USE) UPDATES DURING THIS CASE, PAUSE 5 SECONDS BEFORE MOVING ANTENNA AFTER ABLATION CYCLE ENDS AND NO LATERAL FORCE TO ANTENNA THROUGH NEEDLE GUIDE OR WHEN ANTENNA WAS ADVANCED INTO PATIENT. WHEN THE ANTENNA WAS REMOVED AFTER THE 2ND ABLATION CYCLE, THE DOCTOR NOTICED THAT THE CERAMIC TIP OF THE ANTENNA REMAINED IN THE LIVER AFTER ABLATION. AN IMAGING WAS DONE TO IDENTIFY LOCATION OF THE TIP THAT WAS DEEP IN THE 8TH SEGMENT. THE PHYSICIAN WAITED A COUPLE OF SECONDS AFTER THE ABLATION AND ROTATED THE ANTENNA BEFORE SLOWLY REMOVING IT (HOT RETRACTION). FOR THE LAST ABLATION, A NEW ANTENNA WAS OPENED. THE INTERVENTION COULD BE FINISHED AS PLANNED WITH NO NOTICEABLE COMPLICATIONS OTHER THAN THE MENTIONED INCIDENCE. THE PATIENT WAS AWARE THAT THE TIP WAS LEFT BEHIND AND REMOVAL WAS ANTICIPATED IN THE

    Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Device Embedded In Tissue or Plaque; Foreign Body In Patient; No Code Available

    MAUDE report 10381825 ↗
  • InjuryMay 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING ABLATION, THE COMPONENT OF THE DEVICE WAS LOOSE WHEREIN THE CERAMIC TIP REMAINED IN THE LIVER OF PATIENT SEEN IN COMPUTED TOMOGRAPHY (CT) SCAN. THE PROCEDURE WAS ABORTED BUT THE PATIENT WAS IN GENERAL ANESTHESIA. THE PHYSICIAN CHANGED TO MEDICATION THERAPY.

    Patient problems: Device Embedded In Tissue or Plaque; No Code Available; Radiation Exposure, Unintended

    MAUDE report 10054588 ↗
  • MalfunctionMar 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE, THE DEVICE'S SPIKE CAP FELL OFF.

    Patient problems: No Information

    MAUDE report 9777254 ↗
  • InjuryFeb 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING PERCUTANEOUS ABLATION, THE TIP GOT LOOSE AND DISENGAGED BUT THERE WAS NO LATERAL FORCE TO ANTENNA THROUGH NEEDLE GUIDE OR ONCE ANTENNA IS ADVANCED INTO PATIENT. COMPUTED TOMOGRAPHY (CT) SCAN WAS INITIATED TO LOCATE THE DISENGAGED TIP WHEREIN IT WAS LOCATED IN THE CAPSULA OF THE LIVER. THE TIP REMAINED IN PATIENT AND WILL NOT BE REMOVED.

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

    MAUDE report 9738527 ↗
  • MalfunctionFeb 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING ABLATION, THE CERAMIC TIP BROKE OFF INSIDE THE PATIENT.

    Patient problems: No Information

    MAUDE report 9726496 ↗
  • MalfunctionJan 30, 2020No Flow; Temperature Problem; No Flow; Temperature Problem

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT FIRST, THE SALINE WAS FOUND TO BE FLOWED NORMALLY, BUT THE FLOW GRADUALLY DECREASED AND THE LIQUID STOPPED FLOWING. AFTER THAT, HIGH TEMPERATURE ERROR OCCURRED. THE PUMP WAS CYCLING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9648014 ↗
  • DeathJan 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AFTER MICROWAVE ABLATION THERAPY WAS PERFORMED, IT RESULTED IN INTRAPERITONEAL BLEEDING AND THE PATIENT DIED. ACCORDING TO COMPUTERIZED TOMOGRAPHY (CT) EXAMINATION, IT WAS CONSIDERED THAT THE BLEEDING WAS FROM THE ROUTE OF PUNCTURE. IT WAS ALSO NOTED BY THE DOCTOR THAT THE BLEEDING OCCURRED FROM THE ANTENNA PUNCTURE ROUTE DUE TO HEPATIC ARTERY DAMAGE AT TREATED SITE.

    Patient problems: Blood Loss; Death

    MAUDE report 9578608 ↗
  • MalfunctionJan 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING LIVER ABLATION, THE SURGEON HAD DIFFICULTIES TO REMOVE THE ANTENNA FROM THE HOLE AFTER ABLATING THE LIVER. ANTENNA WAS REMOVED FROM THE LIVER BUT STILL INSIDE THE PATIENT'S CAVITY. THE ANTENNA WAS BENT ACCIDENTALLY AND BROKEN INTO PIECES. INVESTIGATION OF THE PHOTO SUBMITTED SHOWED THE ANTENNA WAS BROKEN INTO PIECES. BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT'S CAVITY USING LAPAROSCOPIC FORCEPS. THERE WAS NO PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9569744 ↗
  • InjuryDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, UPON WITHDRAWAL OF ABLATION PROBE/ NEEDLE FROM PATIENT, THE TIP OF THE DEVICE BROKE OFF. A PORTION OF THE NEEDLE WAS ATTEMPTED TO BE EXTRACTED BY DOCTOR BUT UNSUCCESSFUL. ANOTHER ATTEMPT WAS MADE UNDER FLUOROSCOPY BUT WAS UNSUCCESSFUL.

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

    MAUDE report 9453280 ↗
  • MalfunctionNov 13, 2019No Flow; No Flow

    ACCORDING TO THE REPORTER, PRE-OPERATIVELY, AIR WAS ACCUMULATED IN THE TUBE, PRIMING WAS UNABLE TO BE PERFORMED. ANOTHER DEVICE WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Patient Involvement

    MAUDE report 9319302 ↗

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-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

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Sources and updates

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