Emprint CAPUMP1Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521190788), received between Dec 8, 2021 and Feb 18, 2025 — classified as 1 death, 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “No Flow” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2025Connection Problem; No Flow; Connection Problem; No Flow

  IT WAS REPORTED THAT DURING A LIVER CANCER TREATMENT USING THE DEVICE, SEVERAL ISSUES WERE ENCOUNTERED WITH THE ABLATION PUMP. THE COOLING WATER DID NOT CIRCULATE DESPITE THE PUMP MOTOR ROTATING, AND THE MECHANISM ON THE BOTTOM OF THE PUMP DID NOT MOVE UPWARDS EVEN WHEN THE LID WAS CLOSED. ADDITIONALLY, THE TUBE WAS NOT CLAMPED, REQUIRING THE DOCTOR TO MANUALLY HOLD IT DOWN. DESPITE THESE ISSUES, THE ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394864 ↗
• InjuryOct 10, 2024Failure to Fire; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PUMP WAS NOT FUNCTIONAL. THE PROCEDURE WAS STOPPED FOR COUPLE OF MINUTES AND CONV ERTED TO RESECTION. PATIENT WAS UNDER ANESTHESIA.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20420808 ↗
• MalfunctionSep 12, 2024Leak/Splash; No Flow; Leak/Splash; No Flow

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PUMP WAS NOT WORKING NORMALLY 100% OF THE TIME, IT HAD LEAKS AND SOMETIMES HAVING TROUBLE TO PROCEED TO THE WATER CIRCULATION. THE PROCEDURE WAS COMPLETED USING THE REPORTED DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20203593 ↗
• InjurySep 4, 2024Smoking; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Smoking; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THE UNITS HAD BURNING SMELL AND STOPPED WORKING. THE PROCEDURE WAS CANCELLED AND WAS PUT UP IN SOME OTHER TIME. PATIENT ALREADY UNDER ANESTHESIA AT THE TIME OF THE EVENT. THE UNITS WERE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 20134733 ↗
• DeathMay 17, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE GENERATOR ALARMS SOUNDED AND IT DID NOT REACH THE TEMPERATURE. THE PROCEDURE WAS ABORTED-PATIENT UNDER ANESTHESIA AND COULD NOT BE PERFORMED BECAUSE THE PATIENT WAS BLEEDING. SURGEON CAUTERIZE THE BLEEDING. PATIENT WAS ADMITTED TO INTENSIVE CARE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19342987 ↗
• MalfunctionMar 14, 2024No Flow; No Flow

  ACCORDING TO THE REPORTER, THE COOLING CIRCUIT PLUG WAS NOT WORKING.

  Patient problems: Insufficient Information

  MAUDE report 18909057 ↗
• MalfunctionOct 24, 2023No Flow; No Flow

  ACCORDING TO THE REPORTER, THE WATER COOLING SYSTEM WAS NOT WORKING.

  Patient problems: Insufficient Information

  MAUDE report 17998839 ↗
• MalfunctionOct 5, 2022Energy Output Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Energy Output Problem; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE GENERATOR SWITCHED ITSELF POWER AND TIME. IT ALWAYS SETS ITSELF TO 100W AND 10 SECONDS NO MATTER WHAT WAS PREVIOUSLY SET. IT HAD INTERMITTENT ACTIVATION. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS LESS THAN 30 MINUTES UNDER ANESTHESIA. THEY TESTED EVERY PART OF THE SYSTEM SEPARATELY AND CHANGED PIECE AFTER PIECE WITH ITS OWN SYSTEM, BUT ONLY THE GENERATOR HAD THE MALFUNCTION. ANOTHER GENERATOR WAS USED WITH THE SAME HANDPIECE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544424 ↗
• MalfunctionMar 24, 2022No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, WHEN PERFORMING THE PRIMING, AIR CAME IN AND THE CIRCULATION DID NOT GO PROPERLY. THEY CHANGED TO ANOTHER ANTENNA AND TRIED, BUT THE AIR ENTERED AND COULD NOT CIRCULATE AS THE SAME. WHEN THEY HELD DOWN THE HAND ON THE LID OF THE PUMP FROM ABOVE, IT WAS ABLE TO CIRCULATE WITHOUT AIR ENTERING. WHEN THEY TOOK THE HAND OFF, AIR WOULD ENTER, SO THEY HELD THE LID DOWN DURING THE PROCEDURE AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891428 ↗
• MalfunctionDec 8, 2021No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE WATER DID NOT FLOW INTO THE TUBE AND THE OUTPUT STOPPED. THEY USED ANOTHER LIKE DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12959754 ↗