Emprint CA30L2 (UDI 10884521806566)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521806566), received between Dec 16, 2021 and Feb 2, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (6 reports).

3 other recalls cover devices cleared under the same FDA submission (K163105); they may or may not involve this specific model.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Overheating of Device; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT A PATIENT WITH CIRRHOSIS, HEPATOCELLULAR CARCINOMA WAS TREATED WITH MICROWAVE ABLATION FOR A LIVER TUMOR. AN UNINTENDED TISSUE DAMAGE WAS OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL PRODUCT, AND THERE WAS NO DELAY IN OVERALL PROCEDURE TIME OR NEED FOR ADDITIONAL TREATMENT OR SURGERY. NO ERROR OR MESSAGES OCCURRED DURING PROCEDURE. SETTING WERE 150 WATTS FOR 2:30 MINUTES FOR A 3.5 X 4.1 CM ABLATION. HOWEVER, ON POST OPERATIVE DAY 1 CT (COMPUTED TOMOGRAPHY) SCAN, THE ABLATION CAVITY WAS UP TO 5.9 CENTIMETER IN DIAMETER, WELL ABOVE THE PREDICTED ABLATION DIAMETER OF 4.1 CENTIMETER. CT IMAGING ARGUE FOR SOME HEPATIC STEATOSIS, IN ADDITION TO CIRRHOSIS.

  Patient problems: Tissue Breakdown

  MAUDE report 24233752 ↗
• MalfunctionMay 1, 2025Device Alarm System; No Flow; Device Alarm System; No Flow

  IT WAS REPORTED THAT DURING PROCEDURE, THE EQUIPMENT ACTIVATED A LOW TEMPERATURE ALERT AND WAS NOT FUNCTIONING PROPERLY, AS THE NEEDLE DID NOT COOL DOWN. THE PROCEDURE WAS COMPLETED WITH THE NEW DEVICE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940841 ↗
• InjurySep 11, 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 PROCEDURE, ATTEMPTED ABLATION ON CAGEN1 GENERATOR AND UNABLE TO ABLATE WITH A "?" ERROR. SWITCHED TO EMPRINT SX MACHINE AND RECEIVED ANTENNA STATE = 4 THERMAL LIMIT EXCEEDED AND ABLATION STATE = 16 GENERAL ERROR CODES. AFTER OPENING THE THIRD ANTENNA AND UNABLE TO ABLATE, THE PROCEDURE WAS ABORTED (PATIENT UNDER ANESTHESIA) AND PATIENT WAS UNABLE TO GET ABLATION PROCEDURE, BUT THE SURGEON MOVED FORWARD WITH DISSECTION PROCEDURE/LIVER RESECTION. LESION REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 20195741 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY REPORTED AN INSTITUTION¿S RESULTS OF DIFFERENT IMAGE-GUIDED ABLATION TECHNIQUES FOR THE TREATMENT OF RENAL CELL CARCINOMA BETWEEN JANUARY 2012 AND OCTOBER 2021. IT WAS NOTED THAT MICROWAVE ABLATION WAS CARRIED OUT WITH A 13G INTERNALLY COOLED IMPRINT ANTENNA. THERE WERE 34 PATIENTS WHO UNDERWENT TREATMENT OF 44 TUMORS. COMPLICATIONS INCLUDED PANCREATIC FISTULA AND PERILESIONAL HEMATOMA, BOTH OF WHICH RESULTED IN PROLONGED HOSPITALIZATION.

  Patient problems: Fistula

  MAUDE report 18464642 ↗
• InjuryMar 14, 2023Device 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, THREE DEVICES HAD TEMP STATE 3 ERRORS WHEN TRYING TO USE. TRIED A DIFFERENT REUSABLE CABLE AND A DIFFERENT GENERATOR TO TROUBLESHOOT THE ISSUE. REPLACED THE ANTENNA WITH THE SAME LOT NUMBER AND DIFFERENT LOT BUT THE ISSUE DID NOT RESOLVE. THE PATIENT WAS UNDER ANESTHESIA AND AN INCISION HAD BEEN MADE. THE PROCEDURE WAS ABORTED AND RESCHEDULED FOR THE FOLLOWING WEEK AND WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16540106 ↗
• MalfunctionFeb 27, 2023Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STATEMENT OF "3" AND HAD TEMPERATURE ERRORS. TROUBLESHOOTING STEPS: TRIED A DIFFERENT REUSABLE CABLE AND A DIFFERENT GENERATOR. NEXT STEPS: REPLACED ANTENNA. THERE WAS NO PATIENT INJURY AND PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444626 ↗
• MalfunctionFeb 27, 2023Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD TEMP ERRORS (ANTENNA STATE 3). TROUBLESHOOTING STEPS: TRIED A DIFFERENT REUSABLE CABLE AND GENERATOR. THE ANTENNA WAS REPLACED. THERE WAS NO PATIENT INJURY BUT THE PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444054 ↗
• InjuryFeb 27, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD TEMP STATE THREE ERRORS WHEN TRYING TO USE. TRIED A DIFFERENT REUSABLE CABLE AND A DIFFERENT GENERATOR TO TROUBLESHOOT THE ISSUE THEN REPLACED THE ANTENNA. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444016 ↗
• MalfunctionFeb 27, 2023Device Alarm System; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STATEMENT OF "3" AND HAD TEMPERATURE ERRORS. TROUBLESHOOTING STEPS: TRIED A DIFFERENT REUSABLE CABLE AND A DIFFERENT GENERATOR. NEXT STEPS: REPLACED ANTENNA. THERE WAS NO PATIENT INJURY AND PROCEDURE WAS ABORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16442907 ↗
• MalfunctionFeb 22, 2023Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD TEMP ERRORS (ANTENNA STATE 3). THE ANTENNA AND GENERATOR WAS REPLACED. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416465 ↗
• InjuryFeb 22, 2023Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE HAD TEMP STATE THREE ERRORS WHEN TRYING TO USE. TRIED A DIFFERENT REUSABLE CABLE AND A DIFFERENT GENERATOR TO TROUBLESHOOT THE ISSUE THEN REPLACED THE ANTENNA. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416450 ↗
• InjuryDec 16, 2021Leak/Splash; Detachment of Device or Device Component; Scratched Material; Leak/Splash; Detachment of Device or Device Component; Scratched Material

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD WATER LEAKAGE FROM THE ANTENNA AND HAD SCRATCHED DAMAGE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE DEVICE HAD A DAMAGED/MISSING INSULATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13017651 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163105. One submission often covers many models, so check the product and lot details in each record.

• Z-0627-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of sof
• Z-0626-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation)
• Z-0625-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology, Material CA30L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) o