Emprint CA30L1 (UDI 10884521189553)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521189553), received between Jan 25, 2016 and May 16, 2022 — classified as 1 death, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 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-0560-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2022Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD NO ENERGY OUTPUT. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414228 ↗
• MalfunctionMay 13, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A WATER LEAKAGE. PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14397572 ↗
• MalfunctionFeb 7, 2022Device Alarm System; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Device Alarm System; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING PERCUTANEOUS PROCEDURE, AFTER THE NEEDLE WAS INSERTED FOR 45W FOR 1 MINUTE, THE HIGH-TEMPERATURE ALARM STOPPED THE MACHINE AND THE MACHINE COULD NOT BE STARTED AGAIN. THE NEEDLE STILL COULD NOT BE RE-STARTED AFTER THE NEEDLE WAS REMOVED. THE SURGEON SWITCHED TO RADIOFREQUENCY ABLATION. THE PROCEDURE WAS ABORTED.

  Patient problems: Insufficient Information

  MAUDE report 13472309 ↗
• InjuryAug 6, 2021Leak/Splash; No Flow; Leak/Splash; No Flow

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE DEVICE HAD A CIRCULATION ISSUE - LEAKS WAS PRESENT. THE PROCEDURE WAS ABORTED AND WAS RESCHEDULED. PATIENT WAS UNDER GENERAL ANESTHESIA.

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

  MAUDE report 12291199 ↗
• MalfunctionMay 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PERCUTANEOUS HEPATIC ABLATION, AFTER SEVERAL ATTEMPTS TO POSITIONING INTO LIVER THE PHYSICIAN SAW THE SHAFT ABNORMALLY CURVED AND DECIDED TO PULL OUT THE DEVICE´S POINT FROM PATIENT'S CAVITY. WHEN ALL OF THE SHAFT CAME OUT FROM PATIENT'S CAVITY ,IN THAT MOMENT THE DISTAL POINT OF SHAFT DISENGAGED. NOTHING LEFT INSIDE OF PATIENT CAVITY. REPLACED WITH NEW SIMILAR DEVICE AND IT WORKED FINE WHICH COMPLETED THE PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579399 ↗
• DeathAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER SIX CYCLES OF ABLATION WAS PERFORMED WITH EACH HAD SIX MINUTES DURATION AT 100 WATTS, A BLEEDING WITH A BIG HEMATOMA OCCURRED FROM ONE OF THE NEEDLE TRACKS IN THE LIVER. THEY NOTED THAT AN ANONYMIZED CD WITH CT SCANS WAS AVAILABLE. THEY SUCCESSFULLY STOPPED THE BLEEDING BY CATHETER EMBOLIZATION AND THE PATIENT WAS STABILIZED. THE BLEEDING DID NOT OCCUR FROM ABLATION AREA, BUT FROM A VESSEL ON ONE OF THE ANTENNA TRAJECTORIES. THE PATIENT WAS PLACED IN THE INTENSIVE CARE UNIT DUE TO THE HEMORRHAGE THAT OCCURRED DURING THE LIVER ABLATION PROCEDURE. TWO DAYS AFTER THEY PERFORMED NECESSARY RESUSCITATION ON THE PATIENT, BUT WERE NOT SUCCESSFUL AND THE PATIENT DIED. THE SITE INDICATED THAT THE ABLATION SYSTEM WORKED PROPERLY. A CAUSE OF DEATH HAS NOT YET BEEN DETERMINED, BUT SEPSIS, LIVER AND KIDNEY FAILURE, AND A LUNG EMBOLISM ARE POSSIBLE.

  Patient problems: Blood Loss; Death

  MAUDE report 7781369 ↗
• MalfunctionFeb 17, 2016Temperature Problem

  THE CUSTOMER REPORTED THAT DURING A LIVER ABLATION PROCEDURE, THE ANTENNA WAS SET UP TO THE IV FLUID BAG AND PUMP ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE WAS USED SUCCESSFULLY FOR THE FIRST ABLATION. THE DEVICE WAS REPOSITIONED TO ABLATE AT ANOTHER LOCATION. AFTER OPERATING FOR APPROXIMATELY 5 SECONDS THE GENERATOR EXPERIENCED A 'HIGH TEMP ALARM'. THE NURSE PRESSED THE 'RESET' BUTTON AND THE GENERATOR AGAIN DISPLAYED A 'HIGH ALARM'. AFTER TRYING THIS 3 TIMES, THE NURSE NOTICED THAT THERE WAS NO DRIPPING IN THE DRIP CHAMBER. THE TUBING WAS INSPECTED FOR KINKS AND NONE WERE FOUND. THE TUBING WAS TAKEN OUT OF THE PUMP AND THEN PUT BACK INTO THE PUMP. THE NURSE THEN HIT THE 'RESET' BUTTON AND AGAIN THE GENERATOR DISPLAYED A 'HIGH ALARM'. THE USE OF THE SYSTEM WAS DISCONTINUED. THE PROCEDURE WAS NOT COMPLETED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5442258 ↗
• MalfunctionJan 29, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT DURING A SURGICAL LIVER ABLATION PROCEDURE, THE PUMP WAS ACTIVATED BUT THE WATER FLOW WAS DISTURBED. WHEN THE GENERATOR WAS ACTIVATED THERE WAS A TEMPERATURE ALERT AND THE ANTENNA WOULDN'T WORK. ANOTHER ANTENNA WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5398467 ↗
• MalfunctionJan 25, 2016Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT DURING A WORKSHOP IN (B)(4) (COVIDIEN DISTRIBUTOR) THE UNIT INTERRUPTED THE WATER FLOW SHORTLY AFTER THE BEGINNING OF THE ABLATION ON THE BOVINE LIVER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5387632 ↗