IntelliBlate Ximitry Probe Assembly, 13G x 20cm IB-XPA-1320Recalls & reported problems
Varian Medical Systems, Inc. · IntelliBlate Ximitry probe assembly includes cassette with saline tubing, Ximitry laser alignment disc, and microwave ablation probe 13G/20cm Probe QTY 1 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810563022308), received between Oct 31, 2024 and Oct 31, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
LIVER ABLATION OF A SMALL HCC MASS USING THE INTELLIBLATE SYSTEM AND ASSOCIATED XIMETRY PROBE ASSEMBLY. PLACEMENT OF A SINGLE XPA AND THE ABLATION WAS PERFORMED WITH NO ISSUES. FOLLOWING THE ABLATION, THE POST CT SCAN SHOWED EVIDENCE OF ACTIVE HEMORRHAGE. PATIENT WAS MOVED TO THE ANGIOGRAPHY SUITE WHERE AN ANGIOGRAM IDENTIFIED THE SOURCE OF BLEEDING. THE PSEUDO ANEURYSM WAS SUCCESSFULLY EMBOLIZED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON (B)(6). DR. REPORTS ON (B)(6) THAT THE PATIENT IS DOING WELL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20582491 ↗
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- Emprint CA20L1Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 recall18 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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