Emprint CA15L1 (UDI 10884521189539)Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10884521189539), received between Jan 21, 2016 and Dec 6, 2021 — classified as 9 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

1 FDA recall record name this device's identifier, 1 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, 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. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE YELLOW SILICONE TUBE AND THE WHITE WATER PIPE CONNECT SUDDENLY LEAKING AFTER ABOUT THREE MINUTES OF POWER-ON, IT WAS NOTED THERE WAS A DISENGAGED BUT NOTHING FELL INTO PATIENTS CAVITY. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933831 ↗
• MalfunctionOct 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING TUMOR LESION ABLATION IN THE LIVER, WHEN PUNCTURING OF THE TUMOR, THE NEEDLE TUBE OF THE MIDDLE SECTION OF THE ABLATION NEEDLE WAS BROKEN. THE NEEDLE WAS ALWAYS IN THE HANDS OF THE SURGEON BEFORE AND AFTER THE NEEDLE BREAKAGE PROCESS AND NOTHING FELL INTO THE PATIENT'S CAVITY. AN ULTRASOUND EXAMINATION WAS PERFORMED AND NO BROKEN PIECE WAS FOUND. THEY USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12710058 ↗
• MalfunctionSep 7, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD LEAK. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY. TWO PHOTOGRAPH WERE RECEIVED AND SHOWED THE WATER LEAK AT THE CONNECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12433533 ↗
• MalfunctionSep 1, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD LEAK. THE PROCEDURE WAS ABORTED AND PATIENT WAS UNDER ANESTHESIA.

  Patient problems: Awareness During Anesthesia; Oversedation

  MAUDE report 12410666 ↗
• MalfunctionAug 3, 2021Break; 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'S WATER TUBE WAS BROKEN. THE PROCEDURE WAS CANCELLED AND SET TO ANOTHER SCHEDULE. THE OPERATION WAS COMPLETED AFTER REPLACING A NEEDLE. PATIENT WAS UNDER ANESTHESIA.

  Patient problems: Awareness During Anesthesia; Oversedation

  MAUDE report 12266606 ↗
• MalfunctionAug 3, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE YELLOW SILICONE TUBE OF THE MICROWAVE ABLATION NEEDLE HAD A BREAKAGE IN THE JOINT WITH THE WHITE WATER TUBE. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12266586 ↗
• MalfunctionJun 30, 2021Device Damaged Prior to Use; Adverse Event Without Identified Device or Use Problem; Device Damaged Prior to Use; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS UNWRAPPED AND FOUND THAT THE PIPE WAS BROKEN. THE PROCEDURE WAS THEN ABORTED BUT THE PATIENT WAS ALREADY UNDER SEDATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093068 ↗
• MalfunctionApr 1, 2021Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, UPON UNBOXING, IT WAS DISCOVERED THAT THE SERUM LINE WAS DETACHED FROM THE DEVICE. THE DEVICE WAS REPLACED PRIOR TO THE PATIENT BEING ANESTHESIZED. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC INITIAL INVESTIGATION FOUND THAT THE SHAFT WAS BROKEN. THE OUTER PART OF THE SHAFT SEPARATED FROM THE INNER PART. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602275 ↗
• InjuryJul 30, 2020Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A KIDNEY ABLATION, THE ABLATION ZONE WAS NOT IN ACCORDANCE TO THE SIZE REFERENCED WHEREIN IT WAS SET UP AT 100 WATTS FOR 3 MINUTES AND THE SIZE WAS SMALLER THAN THE EX-VIVO TABLE. THEY OPENED ANOTHER ANTENNA AND TEST IT WITH NORMAL SALINE SOLUTION (NSS) IN A SMALL CUP, THERE WAS NO BUBBLE THAT CAME OUT, AND AFTER TWO MINUTES, THE WATER WAS STILL NOT WARM. THEY REPLACED IT WITH ANOTHER ANTENNA, IT WORKED WELL DURING TESTING. THEN THE DOCTOR USED IT WITH THE PATIENT, IT MAKE CLOUD FASTER THAN THE OTHER 2 ANTENNAS. THE DOCTOR SPENT APPROXIMATELY 1 HOUR, IN ADDITION FROM HIS CURRENT PRACTICE. THEY DID COMPUTED TOMOGRAPHY (CT) SCAN MANY TIMES TO CONFIRM THE POSITION OF THE ANTENNA TO ABLATED COVER LESSON. THEY ABLATED MANY TIMES MORE WHICH WAS MORE THAN WHAT THEY EXPECTED. WHEN THE PHYSICIAN REVIEWED THE ABLATION RESULTS IN THE LAST CT THE ABLATION PROCEDURE WAS CONSIDERED COMPLETE.

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

  MAUDE report 10344410 ↗
• InjuryJul 30, 2020Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Activation; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A KIDNEY ABLATION, THE ABLATION ZONE WAS NOT IN ACCORDANCE TO THE SIZE REFERENCED WHEREIN IT WAS SET UP AT 100 WATTS FOR 3 MINUTES AND THE SIZE WAS SMALLER THAN THE EX-VIVO TABLE. THEY OPENED ANOTHER ANTENNA AND TEST IT WITH NORMAL SALINE SOLUTION (NSS) IN A SMALL CUP, THERE WAS NO BUBBLE THAT CAME OUT, AND AFTER TWO MINUTES, THE WATER WAS STILL NOT WARM. THEY REPLACED IT WITH ANOTHER ANTENNA, IT WORKED WELL DURING TESTING. THEN THE DOCTOR USED IT WITH THE PATIENT, IT MAKE CLOUD FASTER THAN THE OTHER 2 ANTENNAS. THE DOCTOR SPENT APPROXIMATELY 1 HOUR, IN ADDITION FROM HIS CURRENT PRACTICE. THEY DID COMPUTED TOMOGRAPHY (CT) SCAN MANY TIMES TO CONFIRM THE POSITION OF THE ANTENNA TO ABLATED COVER LESSON. THEY ABLATED MANY TIMES MORE WHICH WAS MORE THAN WHAT THEY EXPECTED. WHEN THE PHYSICIAN REVIEWED THE ABLATION RESULTS IN THE LAST CT THE ABLATION PROCEDURE WAS CONSIDERED COMPLETE.

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

  MAUDE report 10344360 ↗
• InjuryJul 10, 2020Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE GENERATOR STOPPED WORKING AND THE ANTENNA BENT. THE PROCEDURE WAS ABORTED.

  Patient problems: No Code Available

  MAUDE report 10261011 ↗
• MalfunctionNov 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABLATION, THE ANTENNA BROKE OFF FROM ONE-THIRD OF THE TIP. NOTHING FELL INTO PATIENT'S CAVITY. THE DEVICE AS REMOVED. ANOTHER ANTENNA WAS USED TO COMPLETE THE PROCEDURE. AND WAS REMOVED. THE SURGICAL TIME WAS EXTENDED BY FIVE MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9339074 ↗
• MalfunctionNov 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE AFTER THE FIRST ABLATION, THE AXIS OF THE EMPRINT ANTENNA WAS BROKEN. IT WAS DIFFICULT TO PLACE THE ANTENNA FOR THE SECOND ABLATION (ANATOMICAL CONDITIONS) AND, AFTER SEVERAL ATTEMPTS, THE ANTENNA BROKEN OFF OUTSIDE OF PATIENT'S CAVITY. THE DOCTOR USED A DIFFERENT ANTENNA TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268601 ↗
• InjuryOct 9, 2019Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING MICROWAVE ABLATION, AFTER INSERTION OF NEEDLE AND WHEN THE GENERATOR STARTED FOR ABLATION IN ULTRASOUND, THERE WAS NO SIGN THAT THE LIVER ABLATED DUE THIS THE CONSULTANTS WANTED TO EXTRACT NEEDLE. BUT AS THEY EXTRACTED THE NEEDLE, IT BROKE FROM THE MID TO TIP AND ITS CERAMIC COATING COMPLETELY REMAINED IN THE PATIENT AND THEY HAVE TO GAVE ANOTHER INCISION TO THE SKIN TO EXTRACT THE BROKEN NEEDLE. EXTENSION OF THE INCISION BY MORE THAN 1 INCH. CHANGE SURGERY FROM ENDOSCOPIC TO OPEN SURGERY AND THERE WAS UNANTICIPATED TISSUE LOSS OR IRREVERSIBLE DAMAGE.

  Patient problems: Fever; No Code Available

  MAUDE report 9171536 ↗
• MalfunctionJul 10, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A CRACK ON THE DEVICE WHEN PLACED IN THE LIVER. NOTHING FELL INTO THE PATIENT CAVITY AND THE ANTENNA WAS FULLY RETRIEVED. THEY USED A NEW ANTENNA TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8778747 ↗
• InjuryApr 29, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING ABLATION, DURING THE FIRST INSERTION OF ANTENNA, IT WAS BROKEN. MEDICAL INTERVENTION DONE TO REMOVE THE ANTENNA. SURGERY EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 8561885 ↗
• InjuryApr 23, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING ABLATION, AFTER THE FIRST ABLATION, THE ANTENNA WAS BROKEN DURING THE SECOND PUNCTURE. MEDICAL INTERVENTION DONE TO REMOVE THE ANTENNA. THE PROCEDURE EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Code Available

  MAUDE report 8541867 ↗
• MalfunctionApr 16, 2019Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING ABLATION, WHEN INSERTING THE ANTENNA INTO THE PATIENT'S SKIN, THE ANTENNA WAS BROKEN IN HALF. A BROKEN PIECE WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520563 ↗
• InjuryFeb 21, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING KIDNEY ABLATION PROCEDURE, AFTER THE FIRST CYCLE THE PROFESSOR NOTICED THAT THE ANTENNA WAS BROKEN BUT NOTHING DETACHED FROM THE DEVICE AND NOTHING FELL INTO PATIENTS CAVITY. THEY DECIDED NOT TO DO ANOTHER ABLATION CYCLE AND THE PROCEDURE ABORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8358990 ↗
• MalfunctionFeb 1, 2019Break; Break

  ACCORDING TO THE REPORTER, WHILE REMOVING THE DEVICE IN AN ABLATION PROCEDURE, THE DEVICE BROKE. THEY NOTED THAT THE DEVICE¿S OUTER JACKET AND THE STAINLESS STEEL TUBE WERE SEPARATED. THEY ALSO NOTED THAT DUE TO THIS EVENT THEY PERFORMED ADDITIONAL MEDICAL INTERVENTION AND THE PROCEDURE WAS EXTENDED FOR MORE THAN 30MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8299112 ↗
• MalfunctionSep 7, 2018Break; Leak/Splash; No Flow; Break; Leak/Splash; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PROFESSOR NOTICED THAT THE ANTENNA'S TUBE WAS TORN AND THE WATER SPILLED. THE TEMPERATURE OF THE GENERATOR ROSE DUE TO THE LEAK. HE HELD THE TWO PIECES OF PIPE TOGETHER AND FINISHED THE FIRST ABLATION, BUT COULD NOT DO ANOTHER ABLATION. THE GENERATOR TURNED OFF. THE DOCTOR HAD TO FINISH THE OPERATION USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7854982 ↗
• MalfunctionSep 4, 2018Leak/Splash; No Flow; Leak/Splash; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE. THE ANTENNA'S TUBE WAS TORN AND THE WATER SPILLED. THEY HELD THE TWO PIECES OF TUBE TOGETHER AND FINISHED THE PROCEDURE. BECAUSE OF THE CIRCULATION ISSUE THE GENERATOR SHOWED A TEMPERATURE ALARM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7843384 ↗
• MalfunctionAug 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE MICROWAVE ABLATION PROCEDURE, THE COOLING CONNECTION OF THE PROBE WAS BROKEN, NOTHING FULLY DETACHED WITH THE DEVICE. NOTHING FELL INTO PATIENTS CAVITY. THEREFORE THE CASE WAS COMPLETED BY USING ANOTHER PROBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822520 ↗
• MalfunctionAug 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LIVER MICROWAVE ABLATION PROCESS, THE ABLATION PROBE'S COOLING LINE WAS DETACHED DURING THE PROCESS BUT NOTHING FELL INTO PATIENTS CAVITY. THEREFORE THE CASE WAS COMPLETED BY USING A NEW PROBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7819805 ↗
• MalfunctionAug 27, 2018Break; No Flow; Break; No Flow

  ACCORDING TO THE REPORTER, DURING A KIDNEY TUMOR ABLATION, THEY NOTICED THAT THE TUBE WAS TORN AND THE WATER SPILLED. THEY HELD THE TWO PIECES OF PIPE TOGETHER AND FINISHED THE FIRST ABLATION, BUT THEY COULD NO LONGER PERFORM ANOTHER ABLATION. THE GENERATOR HAD AN ALARM BECAUSE OF THE LEAK AND THEN TURNED OFF. THEY OPENED A NEW ANTENNA TO COMPLETE THE CASE. THEY NOTED THAT PUMP ALSO HAD A CIRCULATION ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 7819629 ↗