Emprint CA20L1 (UDI 10884521189546)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521189546), received between Mar 17, 2016 and Oct 29, 2022 — classified as 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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-0558-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2022Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT ACTIVATE. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15695799 ↗
• MalfunctionJun 4, 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 LIVER TUMOR ABLATION, THREE DEVICES HAD LEAK AND THE PROCEDURE WAS ABORTED. PATIENT WAS UNDER IN LOCAL ANESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942389 ↗
• MalfunctionJun 4, 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 LIVER TUMOR ABLATION, THREE DEVICES HAD LEAK AND THE PROCEDURE WAS ABORTED. PATIENT WAS UNDER IN LOCAL ANESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942372 ↗
• MalfunctionJun 4, 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 LIVER TUMOR ABLATION, THREE DEVICES HAD LEAK AND THE PROCEDURE WAS ABORTED. PATIENT WAS UNDER IN LOCAL ANESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11942350 ↗
• MalfunctionFeb 25, 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 ABLATION PROCEDURE, ONE OF THE DEVICES HAD A LEAK AND WAS SEVERELY SCABBED. THE SCAB WAS AT THE JUNCTION OF THE CERAMIC END AND THE HEATING END, WHICH MADE IT IMPOSSIBLE TO PULL OUT OF THE PATIENT SMOOTHLY AFTER THE ABLATION OPERATION, AND THE NEEDLE PATH COULD NOT BE ABLATED. FORCIBLY PULLED OUT THE BODY SURFACE TO BRING OUT THE ABLATED TISSUE. IT WAS MAINLY CONCENTRATED AT THE JUNCTION OF THE CERAMIC TIP AND THE HEATING END. THE OTHER TWO NEEDLES WERE BROKEN IN THE CIRCULATING WATER PIPE, WHICH CAUSED THE OPERATION TO FAIL AND THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11377643 ↗
• InjuryJan 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTED, DURING THE MICROWAVE ABLATION (MWA), DURING PUT AND PULL BACK IN THE LIVER, THE DEVICE'S CERAMIC TIP AND THE BODY WAS SEPARATED AND REMAIN IN THE SEGMENT 7 NEAR INFERIOR VENA CAVA (IVC) OF THE LIVER. WHILE TARGETING THE CANCER TISSUE WITH THE ANTENNA, THE TIP WAS NOT VISIBLE TO THE ULTRASOUND, SO IT CAME OUT WITHOUT THE CERAMIC TIP AND THE GREEN FRONT PART. WITH THE SECOND ANTENNA, PROCEDURE WAS SUCCESSFULLY FINISHED IN DIFFERENT SITE. THE SURGERY WAS EXTENDED BY 30 MINUTES AND MORE. TARGET SITE WAS DIFFICULT TO REACH. MEDICAL INTERVENTION WAS ALSO DONE. IT WAS NOTED THAT NEEDLE GUIDE WAS NOT USED TO AID IN THE INSERTION OF THE ANTENNA AND NO INTERACTION OR UNUSUAL FORCE APPLIED WITH ANTENNA TIP. THERE WAS NO INTERVENTION DONE TO RETRIEVE THE GREEN PART OF THE DEVICE. THE SURGEON HAD ABOUT 100 CASES OF MW EXPERIENCE WITHOUT COMPLAINTS. THE SURGEON BROKE THE TIP PART OF THE SECOND ANTENNA TO TEST AND SEE THE RESULTS. TWO PHOTOGRAPHS WERE RECEIVED. FIRST PHOTO SHOWED THE SECOND ANTENNA WHICH WAS BROKE BY THE SURGEON. THE SECOND PHOTO SHOWED THE TIP OF THE ANTENNA IN PATIENT'S LIVER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Device Embedded In Tissue or Plaque

  MAUDE report 11169661 ↗
• InjuryNov 12, 2020Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE PACKAGE WAS OPENED AND THE WATER CIRCULATION MICROWAVE ABLATION NEEDLE WAS CONNECTED TO THE UNIT, IT HAD NO REACTION. THE PROCEDURE WAS THEN ABORTED.

  Patient problems: No Code Available

  MAUDE report 10829599 ↗
• InjuryAug 24, 2020Break; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Break; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THE CONNECTION BETWEEN THE YELLOW SILICONE TUBE AND WHITE WATER TUBE WAS BROKEN AND LEAKING. THE PROCEDURE WAS ABORTED IN THE 4TH MINUTE.

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

  MAUDE report 10446080 ↗
• InjuryAug 11, 2020Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PERCUTANEOUS LIVER ABLATION, THE DEVICE BROKE DURING USE IN THE PATIENT. THE WATER TUBE CONNECTED TO THE ABLATION NEEDLE WAS LEAKING, CAUSED THE NEEDLE TO FAILED TO ABLATE. THE TIP WAS REMOVED AND NOTHING LEFT FROM THE PATIENT. THE DEVICE OPERATOR ADHERED TO RECENT IFU (INSTRUCTIONS FOR USE) UPDATES DURING THE CASE AND PAUSED 5 SECONDS BEFORE MOVING ANTENNA AFTER ABLATION CYCLE ENDS. THE PATIENT WAS UNDER ANESTHESIA AND 15% OF THE PROCEDURE WAS COMPLETED BEFORE THE PROCEDURE WAS ABORTED.

  Patient problems: No Code Available

  MAUDE report 10391952 ↗
• InjuryJul 21, 2020Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THE ABLATION NEEDLE WATER PIPE WAS LEAKING. THE PROCEDURE WAS ABORTED.

  Patient problems: No Code Available

  MAUDE report 10305207 ↗
• InjuryOct 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, UPON ENTERING THE TIP OF THE ANTENNA INTO THE BODY, NO ALARM SOUNDED. PROCEDURE WAS CANCELLED AND PATIENT WAS UNDER ANESTHESIA.

  Patient problems: No Code Available

  MAUDE report 9202087 ↗
• MalfunctionJun 26, 2019No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING ABLATION, THE ANTENNA HAD CIRCULATION ISSUE RESULTED TO NO COOLING OF THE DEVICE. REPLACED WITH NEW SIMILAR ANTENNA AND IT WORKED FINE WHICH COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735356 ↗
• InjuryApr 18, 2019Device Alarm System; Device Alarm System

  ACCORDING TO REPORTER, DURING MICROWAVE ABLATION, WHEN THE CONTROL UNIT STARTED AFTER SELECTING POWER AND DURATION TIME, REFLECTED POWER TRIP ALARM APPEARED ON THE SYSTEM. RESET THE SYSTEM, RECONNECT THE CABLE AND STOPPED THE SYSTEM FOR TEN MINUTES BUT SAME ALARM APPEARED ON THE SYSTEM. THE SURGEON RESCHEDULED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8527302 ↗
• InjuryDec 3, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NEEDLE WAS BROKEN AND ONLY CONNECTED WITH OTHER PART THROUGH CERAMIC COATING, DUE TO THIS TUMOR WAS NOT ABLATED. CONSULTANT CONTINUED THE PROCEDURE, BUT LESION WAS NOT COVERED AND CONSULTANT RESCHEDULED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8124030 ↗
• InjuryNov 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER WITHAFERIN A (WFA) FOR LIVER CANCER, THE LESION OF THE TUMOR PREVIOUSLY ABLATED WITH PROTON BEAM REOCCURRED. THE DEVICE WAS USED ON THE 4TH DAY, AND THE PROTOCOL WAS 45W FOR ONE MINUTE, 60W FOR ONE MINUTE, 75W FOR THREE MINUTES, AND ROUTE ABLATION WAS PERFORMED AT 60W. AFTER THAT, IT WAS CONFIRMED THAT THE ABLATION WAS WELL PERFORMED AND THE PATIENT CONDITION (THE READINGS FOR THE LIVER) WAS ALSO GOOD. HOWEVER, 3 DAYS LATER, THE PATIENT COMPLAINED OF POOR PHYSICAL CONDITION. UPON CHECK, BLEEDING WAS FOUND FROM THE PUNCTURE ROUTE (ARTERY), AND EMBOLIZATION WAS PERFORMED. THERE WAS NO PROBLEM WITH THE PATIENT CURRENT CONDITION. THE DOCTOR SAID THAT HE HAD NEVER MET BLEEDING EVENT 3 DAYS AFTER A PROCEDURE. THE AMOUNT OF BLEEDING WAS UNKNOWN.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8035324 ↗
• InjurySep 27, 2018No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING A MICROWAVE ABLATION, THE YELLOW ANTENNA TUBE JOINT LEAKED, DUE TO THIS WATER WAS NOT CIRCULATING. THE CONSULTANT CONTINUED THE PROCEDURE TO ONE MINUTE BY TAPPING THE LEAKING JOINT, BUT THE LESION WAS NOT COVERED AND RESCHEDULED THE PROCEDURE AND RE-OPERATION WAS NECESSARY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; No Code Available; No Information

  MAUDE report 7915682 ↗
• InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TRACK ABLATION, AFTER ELEVEN ABLATION CYCLES ON VERY BIG TUMORS HAD BEEN PERFORMED, A PLUG OF CARBONIZED TISSUE, BROADER THAN THE NEEDLE DIAMETER WAS STICKING AT THE ANTENNA TIP. IT COULD NOT BE SEEN BY CT SCAN. THE PLUG CAUSED THE BLEEDING WHILE THE NEEDLE WAS PULLED BACK FROM THE PATIENT BODY. THE BLEEDING NEEDED TO BE STOPPED VIA CATHETER EMBOLIZATION. EMBOLIZATION WAS SUCCESSFUL BUT HAD A LATE COMPLICATION OF LOCAL ABSCESS.

  Patient problems: Abscess; Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7767973 ↗
• MalfunctionMar 17, 2016Break

  THE CUSTOMER REPORTED THAT THE DEVICE WAS BEING POSITIONED WITHIN A LESION WHICH THE SURGEON WISHED TO THERMALLY ABLATE AND THE DEVICE SNAPPED AT THE JUNCTION OF THE SHAFT AND THE ANTENNA HANDLE. THE DEVICE WAS REMOVED WITHOUT ACTIVATION. THE ANTENNA BROKE DURING PLACEMENT BUT DID NOT SEPARATE UNTIL AFTER IT WAS REMOVED FROM THE PATIENT. THE PATIENT WAS LARGE (HIGH BMI) AND REQUIRED A LONGER PROBE TO ACCESS THE LIVER LESION. THERE WAS NO INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED. THEY USED ANOTHER PROBE TO CORRECT THE PROBLEM AND IT WORKED WITHOUT FURTHER CONSEQUENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5508653 ↗