IceRod® 1.5 Cryoablation Needle FPRPR3203Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07290104830198), received between Nov 7, 2024 and Jul 21, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (3 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 18, 2020Class IICompleted

   Complaint trend regarding needle shaft gas leaks.

   Z-0669-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ADVERSE EVENTS OCCURRED, AND CATHETERIZATION WAS REQUIRED. THIS RETROSPECTIVE ANALYSIS AIMED TO COMPARE THE SAFETY AND EFFICACY OF MICROWAVE ABLATION (MWA) VERSUS CRYOABLATION (CA) IN PATIENTS WITH PRIMARY HIGH-RISK PULMONARY NODULES. ALL LUNG MWA AND CA PROCEDURES WERE PERFORMED BY TWO EXPERIENCED (>5 YEARS) INTERVENTIONAL RADIOLOGISTS UNDER COMPUTED TOMOGRAPHY (CT) GUIDANCE. GENERAL ANESTHESIA WAS ADMINISTERED THROUGH A COMBINATION OF INTRAVENOUS AND INHALATIONAL AGENTS. CONTINUOUS MONITORING OF CARDIAC ACTIVITY AND VITAL PARAMETERS WAS MAINTAINED THROUGHOUT EACH PROCEDURE. UPON COMPLETION, A FOLLOW-UP CT SCAN WAS PERFORMED TO DETECT ANY IMMEDIATE COMPLICATIONS, AND PATIENTS WERE SUBSEQUENTLY TRANSFERRED TO AN INPATIENT UNIT FOR OBSERVATION. CRYOABLATION WAS PERFORMED USING VISUAL ICE? SYSTEM WITH ICEROD1.5 CRYOPROBES UNDER CT GUIDANCE TO ENSURE THE TARGETED NODULE WAS ENCOMPASSED BY AN ADEQUATE MARGIN. THE ABLATION PROTOCOL CONSISTED OF THREE FREEZE-THAW CYCLES. THE PROTOCOL INCLUDED A FIRST FREEZE OF 3 MINUTES, A THAW PERIOD OF 3 MINUTES, A SECOND FREEZE LASTING 8 MINUTES, FOLLOWED BY A 5-MINUTE THAW, AND A FINAL 8-MINUTE FREEZE BEFORE ACTIVE THAWING. THE A

  Patient problems: Fever; Hemoptysis; Hemothorax; Pain; Pleural Effusion; Pneumothorax; Unspecified Gastrointestinal Problem

  MAUDE report 25894295 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THERE WAS FROST ALONG THE LENGTH OF THE NEEDLE SHAFT. ICEROD NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE IN THE LIVER. DURING THE PROCEDURE, ABOUT 1-3 MINUTES INTO THE FREEZE, FROST FORMED ON THE SHAFTS OF ALL THE NEEDLES. A GLOVE FILLED WITH HOT WATER WAS USED TO PROTECT THE SKIN FROM FREEZING. THE PROCEDURE WAS CONTINUED WITH THE ORIGINAL NEEDLES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20632398 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THERE WAS FROST ALONG THE LENGTH OF THE NEEDLE SHAFT. ICEROD NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE IN THE LIVER. DURING THE PROCEDURE, ABOUT 1-3 MINUTES INTO THE FREEZE, FROST FORMED ON THE SHAFTS OF ALL THE NEEDLES. A GLOVE FILLED WITH HOT WATER WAS USED TO PROTECT THE SKIN FROM FREEZING. THE PROCEDURE WAS CONTINUED WITH THE ORIGINAL NEEDLES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631500 ↗
• MalfunctionNov 7, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THERE WAS FROST ALONG THE LENGTH OF THE NEEDLE SHAFT. ICEROD NEEDLES WERE SELECTED FOR A CRYOABLATION PROCEDURE IN THE LIVER. DURING THE PROCEDURE, ABOUT 1-3 MINUTES INTO THE FREEZE, FROST FORMED ON THE SHAFTS OF ALL THE NEEDLES. A GLOVE FILLED WITH HOT WATER WAS USED TO PROTECT THE SKIN FROM FREEZING. THE PROCEDURE WAS CONTINUED WITH THE ORIGINAL NEEDLES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20631491 ↗