IntelliBlate Microwave Ablation System Console IB-CONRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00810563022278), received between Nov 26, 2025 and Apr 17, 2026 — classified as 2 deaths, 2 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathApr 17, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  SEE COMPLETED (B)(4) AND MFR 3008262715-2026-0007.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Liver Failure

  MAUDE report 24914861 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  DURING A CT-GUIDED MICROWAVE ABLATION PROCEDURE USING THE INTELLIBLATE MICROWAVE ABLATION SYSTEM, TWO RECURRENT HEPATOCELLULAR CARCINOMA (HCC) LESIONS LOCATED IN THE LEFT HEPATIC LOBE WERE TREATED PER STANDARD PROTOCOL WITH A 3.0 CM TARGET ABLATION ZONE AT 60 W FOR 5 MINUTES EACH. POST-PROCEDURE CT IMAGING DEMONSTRATED ABLATION ZONES EXCEEDING THE INTENDED DIMENSIONS, MEASURING 3.92 × 4.56 CM FOR LESION 1 AND 4.59 × 2.94 CM FOR LESION 2. AT THE 24HOUR CLINICAL EVALUATION, THE PATIENT WAS FOUND TO HAVE AN ULCERATION OF THE DISTAL CORPUS OF THE STOMACH (ANTERIOR WALL, MAJOR CURVATURE), CLASSIFIED AS FORREST IIC AND ASSESSED AS POTENTIALLY ATTRIBUTABLE TO THERMAL INJURY OF THE GASTRIC INNER LAYER. INTRAVENOUS PROTON PUMP INHIBITOR THERAPY AT DOUBLE THE STANDARD DOSE WAS INITIATED. THE PATIENT¿S MEDICAL HISTORY IS SIGNIFICANT FOR RECURRENT HEPATOCELLULAR CARCINOMA WITH PRIOR LAPAROSCOPIC RESECTION OF LIVER SEGMENT IVB (2017), MULTIPLE PRIOR THERMAL ABLATIONS (2021, 2023, 2025), AND PREABLATION TACE, AS WELL AS UNDERLYING LIVER CIRRHOSIS CHILDPUGH A SECONDARY TO RESOLVED HEPATITIS¿C AND HEREDITARY HEMOCHROMATOSIS. THE CURRENT ADVERSE EVENT OCCURRED IN THE CONTEXT OF A COMPLEX TREATMENT

  Patient problems: Stomach Ulceration

  MAUDE report 24250789 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING DETAILS OF THE SURGERY WERE PROVIDED BY THE TREATING PHYSICIAN: ABLATION WAS PERFORMED AT THE SITE. NO IRREGULARITIES OF ABLATION. ABLATION WAS PERFORMED CLOSE TO SURGICAL ANASTOMOSIS. ABLATION WAS OF EXPECTED SIZE HOWEVER IT EXTENDED TO THE BOWEL CAUSING BOWEL INJURY AND REQUIRING SURGERY- PRECISION OF INJURED BOWEL. PATIENT RECOVERING WELL.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 23660864 ↗
• DeathNov 26, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  SEE COMPLETED MW-2025-0014 AND MFR 3008262715-2025-00003.

  Patient problems: Multiple Organ Dysfunction Syndrome

  MAUDE report 23660794 ↗