Emprint CAGEN1ZDRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521552579), received between Feb 22, 2021 and Dec 30, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2021Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THEY ATTEMPTED ABLATION FOR 75 WATTS AT 4 MINUTES. THE GENERATOR HAD THE ANTENNA TEMPERATURE SENSOR ERROR WHILE DOING AN ABLATION THAT ENDING AT 3 MINUTES INSTEAD OF 4 MINUTES. CONFIRMED SALINE WAS FLOWING. CUSTOMER WAS NOT ABLE TO COMPLETE THE PROCEDURE AND IT WAS ABORTED AFTER THE HARD REST (UNPLUGGING ALL POWER CORDS, ANTENNAS AND THEN PLUGGING EVERYTHING BACK IN TO POWER ON). THEY PRESS THE RESET BUTTON AND IT STILL CONTINUED TO SHOW THE TEMP ALERT ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117846 ↗
• MalfunctionDec 1, 2021Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE UNIT HAD AN ERROR AND HAD TO BE RESET SEVERAL TIMES. THE PROCEDURE WAS CANCELLED. THE PATIENT WAS NOT UNDER ANESTHESIA AT THE TIME BUT WAS UNDER CONSCIOUS SEDATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908340 ↗
• MalfunctionMar 11, 2021Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING MICROWAVE ABLATION OF A LIVER TUMOR, AN ERROR MESSAGE "FATAL ERROR" SHOWED IN THE UNIT. IT WAS THE ERROR THE HAND AND THE BOX WITH AN ARROW COMING OUT AND IT WOULD NOT ALLOW TO RESET IT. THE PROCEDURE WAS ABORTED AND RE-SCHEDULED ON THE NEXT DAY WITH NEW GENERATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11463705 ↗
• MalfunctionFeb 22, 2021Failure to Power Up; Adverse Event Without Identified Device or Use Problem; Failure to Power Up; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, TURNED ON WATER PUMP AND GENERATOR PRIOR TO THE PATIENT GETTING ON THE TABLE AND BOTH WORKED. WHEN THE CASE STARTED AND THEY WENT TO HOOK UP THE ANTENNA TO THE WATER PUMP AND THE GENERATOR, THE WATER PUMP DID NOT TURN ON, THEY TRIED A DIFFERENT CORD AND A DIFFERENT OUTLET BUT NEITHER WORKED. THEY HAD TO WAIT AT LEAST 45 MIN TO FIND ANOTHER PUMP. IN THE MEAN TIME THE PATIENT WAS ON THE TABLE AND SEDATED. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 11358592 ↗