HS AMICA AMICA-PROBE (REF APK14150T19V5)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033055147163), received between Feb 25, 2020 and Oct 24, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2022Break; Break

  PATIENT UNDERGOING IMAGE GUIDED MICROWAVE ABLATION OF LIVER LESION. THE FIRST LESION WAS ABLATED AT 60WX10MIN. THE PROBE WAS THEN REPOSITIONED, AND THE ABLATION CONTINUED AT 80WX12MIN. THE PROBE WAS REMOVED AND POSITIONED IN THE SECOND LESION FOR AN ABLATION AT 80WX10MIN. THE PROBE WAS AGAIN REMOVED. CHAR WAS WIPED FROM THE SHAFT. NO DAMAGE TO THE TIP WAS NOTED. MULTIPLE PASSES WERE REQUIRED TO PLACE THE PROBE IN THE THIRD LESION, WHICH WAS ABLATED AT 80WX10MIN. UPON PROBE REMOVAL, IT WAS NOTED THAT TIP WAS NO LONGER ATTACHED. THE RETAINED TIP WAS VISIBLE IN CT IMAGING. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? IMAGE GUIDED MICROWAVE ABLATION OF LIVER LESION. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15658023 ↗
• MalfunctionFeb 25, 2020Material Fragmentation; Material Fragmentation

  MICROWAVE ABLATION OF PT WITH HCC, LIVER, SEG IV 4A, W/CIRRHOSIS, 1.0CM WAS ABLATED AT 100W/15M. TRACK ABLATION AT 40W / 4 S. AFTER AMICA 14G, 15CM WAS REMOVED, DR. NOTICED THAT THE DISTAL TIP REMAINED AT THE EDGE OF THE TUMOR ABLATION ZONE VERIFIED BY CT WAS NOT INTACT AND THE TIP OF THE PROBE WAS AT THE EDGE OF THE TUMOR ABLATION ZONE VERIFIED BY CT. THE POST CT SCAN W/CONTRAST SHOWED GOOD COVERAGE OF THE LESION. NO ADVERSE EVENTS NOTED FOR THE PATIENT A THIS TIME. FDA SAFETY REPORT ID#(B)(4)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9748954 ↗
• MalfunctionFeb 25, 2020Material Fragmentation; Material Fragmentation

  14GX15CM AMICA PROBE TIP MALFUNCTION FOLLOWING STANDARD SAFETY PROTOCOL RESULTING IN DISLODGMENT OF THE PROBE TIP IN THE LIVER DURING ABLATION. THE ABLATION WAS ABORTED WITHIN 15SEC OF THE FIRST ABLATION CYCLE. THE PROBE WAS REMOVED AND A NEW 14GX150MM AMICA PROBE WAS USED TO RE-ATTEMPT ABLATION. FOLLOWING STANDARD SAFETY PRACTICE THE NEW PROBE WAS INSERTED INTO THE AREA OF THE TUMOR. AFTER 1.5MIN INTO THE ABLATION CYCLE, THE MACHINE ABRUPTLY CUT OFF DUE TO SIMILAR ISSUES AS THE FIRST INCIDENT. THE PROBE TIP WAS ALSO FOUND TO BE DISLODGED IN THE LIVER. THE LOT NUMBERS OF THESE TWO DEVICES WERE THE SAME LOT #37210.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9748942 ↗