Emprint CA20L1 (UDI 10884521725959)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521725959), received between Apr 8, 2020 and Sep 25, 2023 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Intermittent Energy Output” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DAMAGED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE NEW DEVICE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE SHAFT WAS BROKEN AND PART OF THE SHAFT HAD DETACHED AND WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17812247 ↗
• MalfunctionApr 13, 2023Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE STOPPED WORKING AND COULD NOT EMIT ENERGY. THE PATIENT HAS BEEN ANESTHETIZED FOR TEN MINUTES AND THE CONSUMABLES WERE REPLACED ON THE SPOT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732067 ↗
• MalfunctionDec 28, 2022Leak/Splash; No Flow; Leak/Splash; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD CIRCULATION ISSUE AND LEAKAGE. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060315 ↗
• MalfunctionDec 22, 2022No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LIVER TUMOR ABLATION, DEVICE FAILED TO CIRCULATE. THE PATIENT HAD SLIGHT BLEEDING, NO BLOOD LOSS COUNT, NO BLOOD TRANSFUSION REQUIRED, NO MEASURES WERE TAKEN TO STOP THE BLEEDING. AFTER THE OPERATION WAS SUSPENDED, A NEW NEEDLE WAS USED INSTEAD AND THE OPERATION WAS COMPLETED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036196 ↗
• MalfunctionDec 5, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A TRANSDERMAL PROCEDURE, WHEN THE NEEDLE WAS INSERTED IT DID NOT ACTIVATE. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY BUT THE PROCEDURE INTERRUPTED AND DID NOT CONTINUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15919359 ↗
• MalfunctionAug 29, 2022Device Alarm System; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Device Alarm System; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER WORKING FOR A PERIOD OF TIME, THE HOST KEPT REPORTING A MICROWAVE LEAKAGE. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316015 ↗
• MalfunctionAug 29, 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 A PROCEDURE, AFTER WORKING FOR A PERIOD OF TIME, THE HOST KEPT REPORTING A MICROWAVE LEAKAGE. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15315958 ↗
• MalfunctionJan 7, 2022Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, AFTER LOCATING THE LESION UNDER COLOR DOPPLER ULTRASOUND, THE NEEDLE TIP PENETRATED THE LESION, PRE-HEATING AT 45W FOR 1MINUTES, 65W FOR 2MINUTES, AND THEN 75W FOR 5MINUTES (SETTING), 4MINUTES AFTER ABLATION, THE MACHINE MALFUNCTIONED, AND THE WATER CIRCULATION WAS NORMAL. THEY CHANGED THE ANTENNA BUT STILL DID NOT WORK. THE ABLATION WAS INCOMPLETE AND THEY CHANGE THE PROCEDURE TACE (TRANSARTERIAL CHEMOEMBOLIZATION) INTERVENTIONAL THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 13192836 ↗
• MalfunctionDec 6, 2021Device Difficult to Setup or Prepare; No Flow; Device Difficult to Setup or Prepare; No Flow

  ACCORDING TO THE REPORTER, THE DEVICE HAD DIFFICULTY TO ASSEMBLE AND FAILURE TO CIRCULATE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS ALREADY ANESTHETIZED. NO FURTHER INFORMATION AVAILABLE.

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

  MAUDE report 12933044 ↗
• MalfunctionDec 3, 2021Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, AFTER ENTERING THE HUMAN BODY, THE YELLOW SILICONE TUBE AND WHITE WATER PIPE CONNECTIONS APPEARED LEAKING AFTER ABOUT 7 MINUTES OF POWER-ON ABLATION. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12924996 ↗
• MalfunctionDec 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 A COMPONENT ISSUE WHEREIN THERE WAS A LEAK IN THE WHITE PIPE CONNECTION. DUE TO THAT, THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908247 ↗
• MalfunctionApr 8, 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 MICROWAVE ABLATION SURGERY, THE TWO DEVICES' ANTENNA WERE DIFFICULT TO ACTIVATE. THE OPERATION WAS INTERRUPTED FOR TWO HOURS BUT THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9936617 ↗
• InjuryApr 8, 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, THE TWO ANTENNA WAS DIFFICULT TO ACTIVATE. THE OPERATION WAS INTERRUPTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9936571 ↗