IntelliBlate Ximitry Probe Assembly, 13G x 15cm IB-XPA-1315Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810563022292), received between Nov 19, 2025 and Mar 17, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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.

• InjuryMar 17, 2026Appropriate Device Problem Term/Code Not Available

  SEE COMPLETED MW-2026-00009, MFR REPORT NUMBER 3008262715-2026-00006.

  Patient problems: Hematoma; Liver Damage/Dysfunction

  MAUDE report 24621355 ↗
• InjuryFeb 3, 2026Use of Device Problem; Insufficient Device Problem Information

  DURING A MICROWAVE ABLATION PROCEDURE USING AN INTELLIBLATE IB-XPA-1315 PROBE, THE SYSTEM TRIGGERED A COOLING SYSTEM ALARM APPROXIMATELY ONE MINUTE AFTER ABLATION BEGAN AT 60 W. UPON RESPONDING TO THE ALARM, THE PHYSICIAN PERFORMED IMAGING AND IDENTIFIED A BOLUS OF AIR WITHIN THE LIVER AND IN THE RIGHT VENTRICLE OF THE HEART. THE PHYSICIAN IMMEDIATELY STOPPED THE SYSTEM AND REMOVED THE PROBE, AT WHICH POINT IT WAS OBSERVED THAT THE DISTAL TIP OF THE PROBE HAD DETACHED AND REMAINED INSIDE THE PATIENT. SUBSEQUENT IMAGING CONFIRMED THAT THE DETACHED TIP WAS RETAINED WITHIN THE LIVER AND APPEARED BROKEN JUST AFTER THE FEEDING POINT, EXHIBITING A SLIGHT BURNT ASPECT. BECAUSE THE COOLING PUMP CONTINUED TO OPERATE FOLLOWING THE TIP DETACHMENT, AIR ENTERED THROUGH THE BROKEN SECTION OF THE PROBE AND MIGRATED INTO THE LIVER VASCULATURE, ULTIMATELY REACHING THE RIGHT VENTRICLE. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT AND WAS MONITORED IN THE ICU FOR TWO DAYS WITHOUT FURTHER INCIDENT. THE DETACHED TIP REMAINS IN THE PATIENT. NO LONG-TERM HEALTH CONSEQUENCES ARE ANTICIPATED. VARIAN HAS REQUESTED ADDITIONAL INFORMATION; THE DAMAGED PROBE WILL BE RETURNED FOR ANALYSIS. THE INVESTIGATION IS ONG

  Patient problems: Air Embolism

  MAUDE report 24250684 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. WAS USING SIEMENS MY NEEDLE LASER TO PLAN AND PLACE THE [MICROWAVE] NEEDLES. AFTER PLACEMENT, THE SCAN SHOW THAT THE PLACEMENT WAS NOT WHERE THE PHYSICIAN HAD INTENDED AND HAD CAUSED A PARTIAL PNEUMOTHORAX OF THE RIGHT LUNG. ISSUES WAS NOT WITH [MICROWAVE] SYSTEM. DR. PLACED A 10F DRAIN AND CASE PROCEEDED WITHOUT FURTHER INCIDENT.

  Patient problems: Pneumothorax

  MAUDE report 23597670 ↗