IceRod® 1.5 MRI 90° Cryoablation Needle FPRPR3195Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07290104830297), received between Mar 16, 2019 and Aug 11, 2022 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (4 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-0678-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A NEEDLE AIR LEAK OCCURRED. AN ICEROD 90 DEGREE MRI NEEDLE WAS SELECTED FOR THE INDEX CRYOABLATION PROCEDURE. DURING PREPARATION, HOWEVER, THERE WAS AN AIR LEAK OBSERVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213922 ↗
• MalfunctionAug 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A NEEDLE AIR LEAK OCCURRED. AN ICEROD 90 DEGREE MRI NEEDLE WAS SELECTED FOR THE INDEX CRYOABLATION PROCEDURE. DURING PREPARATION, HOWEVER, THERE WAS AN AIR LEAK OBSERVED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203975 ↗
• MalfunctionFeb 27, 2020Failure to Fire; Failure to Fire

  4 NEEDLES WERE USED IN A MRI GUIDED RENAL CRYOABLATION PROCEDURE. DURING THE CASE, ALL 4 ICEROD MRI NEEDLES ONLY REACHED AN ICEBALL SIZE OF APPROX. 1 CM, WHICH WAS INSUFFICIENT FOR THE PROCEDURE. EXTRA ACTIVE THAWING CYCLES DID NOT RESOLVE THIS. MULTIPLE FREEZING CYCLES WERE CONDUCTED IN AN ATTEMPT TO REACH AN ACCEPTABLE ABLATION ZONE. THE TREATMENT WAS DEEMED UNSUCCESSFUL, AND A NEW CRYOABLATION PROCEDURE HAS BEEN SCHEDULED FOR THIS PATIENT. ALL FOUR NEEDLES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND THE CRYOABLATION SYSTEM WAS INVESTIGATED IN A FIELD SERVICE CALL. THIS MDR SUMMARISES THE INVESTIGATION RESULTS OF THE FOURTH NEEDLE USED IN THIS COMPLAINT. PLEASE SEE THE FOLLOWING MDR'S FOR THE OTHER DEVICES USED DURING THIS CRYOABLATION PROCEDURE: 3004462490-2020-00001 - CRYOABLATION SYSTEM, 9616793-2020-00035 - NEEDLE 1, 9616793-2020-00036 - NEEDLE 2, 9616793-2020-00037 - NEEDLE 3

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9767066 ↗
• MalfunctionFeb 27, 2020Failure to Fire; Failure to Fire

  4 NEEDLES WERE USED IN A MRI GUIDED RENAL CRYOABLATION PROCEDURE. DURING THE CASE, ALL 4 ICEROD MRI NEEDLES ONLY REACHED AN ICEBALL SIZE OF APPROX. 1 CM, WHICH WAS INSUFFICIENT FOR THE PROCEDURE. EXTRA ACTIVE THAWING CYCLES DID NOT RESOLVE THIS. MULTIPLE FREEZING CYCLES WERE CONDUCTED IN AN ATTEMPT TO REACH AN ACCEPTABLE ABLATION ZONE. THE TREATMENT WAS DEEMED UNSUCCESSFUL, AND A NEW CRYOABLATION PROCEDURE HAS BEEN SCHEDULED FOR THIS PATIENT. ALL FOUR NEEDLES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND THE CRYOABLATION SYSTEM WAS INVESTIGATED IN A FIELD SERVICE CALL. THIS MDR SUMMARISES THE INVESTIGATION RESULTS OF THE FIRST NEEDLE USED IN THIS COMPLAINT. PLEASE SEE THE FOLLOWING MDR'S FOR THE OTHER DEVICES USED DURING THIS CRYOABLATION PROCEDURE: 3004462490-2020-00001 - CRYOABLATION SYSTEM, 9616793-2020-00036 - NEEDLE 2, 9616793-2020-00037 - NEEDLE 3, 9616793-2020-00038 - NEEDLE 4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9767060 ↗
• MalfunctionFeb 27, 2020Failure to Fire; Failure to Fire

  4 NEEDLES WERE USED IN A MRI GUIDED RENAL CRYOABLATION PROCEDURE. DURING THE CASE, ALL 4 ICEROD MRI NEEDLES ONLY REACHED AN ICEBALL SIZE OF APPROX. 1 CM, WHICH WAS INSUFFICIENT FOR THE PROCEDURE. EXTRA ACTIVE THAWING CYCLES DID NOT RESOLVE THIS. MULTIPLE FREEZING CYCLES WERE CONDUCTED IN AN ATTEMPT TO REACH AN ACCEPTABLE ABLATION ZONE. THE TREATMENT WAS DEEMED UNSUCCESSFUL, AND A NEW CRYOABLATION PROCEDURE HAS BEEN SCHEDULED FOR THIS PATIENT. ALL FOUR NEEDLES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND THE CRYOABLATION SYSTEM WAS INVESTIGATED IN A FIELD SERVICE CALL. THIS MDR SUMMARISES THE INVESTIGATION RESULTS OF THE SECOND NEEDLE USED IN THIS COMPLAINT. PLEASE SEE THE FOLLOWING MDR'S FOR THE OTHER DEVICES USED DURING THIS CRYOABLATION PROCEDURE: 3004462490-2020-00001 - CRYOABLATION SYSTEM, 9616793-2020-00035 - NEEDLE 1, 9616793-2020-00037 - NEEDLE 3, 9616793-2020-00038 - NEEDLE 4.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9767059 ↗
• MalfunctionFeb 27, 2020Failure to Fire; Failure to Fire

  4 NEEDLES WERE USED IN A MRI GUIDED RENAL CRYOABLATION PROCEDURE. DURING THE CASE, ALL 4 ICEROD MRI NEEDLES ONLY REACHED AN ICEBALL SIZE OF APPROX. 1 CM, WHICH WAS INSUFFICIENT FOR THE PROCEDURE. EXTRA ACTIVE THAWING CYCLES DID NOT RESOLVE THIS. MULTIPLE FREEZING CYCLES WERE CONDUCTED IN AN ATTEMPT TO REACH AN ACCEPTABLE ABLATION ZONE. THE TREATMENT WAS DEEMED UNSUCCESSFUL, AND A NEW CRYOABLATION PROCEDURE HAS BEEN SCHEDULED FOR THIS PATIENT. ALL FOUR NEEDLES WERE RETURNED TO THE MANUFACTURER FOR INVESTIGATION, AND THE CRYOABLATION SYSTEM WAS INVESTIGATED IN A FIELD SERVICE CALL. THIS MDR SUMMARISES THE INVESTIGATION RESULTS OF THE THIRD NEEDLE USED IN THIS COMPLAINT. PLEASE SEE THE FOLLOWING MDR'S FOR THE OTHER DEVICES USED DURING THIS CRYOABLATION PROCEDURE: 3004462490-2020-00001 - CRYOABLATION SYSTEM, 9616793-2020-00035 - NEEDLE 1, 9616793-2020-00036 - NEEDLE 2, 9616793-2020-00038 - NEEDLE 4

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9767057 ↗
• InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW UP #1 TO REPORT INVESTIGATION FINDINGS. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THAT FOLLOWING A LIVER CRYOABLATION PROCEDURE WITH AN ICEROD MRI NEEDLE, IT WAS NOTICED THAT THE PATIENT HAD A HEAT SKIN BURN. INFORMATION REGARDING TREATMENT OR INTERVENTION WAS NOT PROVIDED. THE NEEDLE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Burn, Thermal

  MAUDE report 9266838 ↗
• InjuryMar 16, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A MRI PROCEDURE THERE WAS OBSERVATION OF A SKIN BURN DUE TO AN APPARENT PROCEDURAL ISSUE. DURING FOLLOW-UP, THE DOCTOR CONFIRMED THAT HE DOES NOT USE ANY FORM OF EXTERNAL/TOPICAL SKIN PROTECTION AS A STANDARD OF PRACTICE. HE STATED THAT THEY HAD A GLOVE FILLED WITH WARM SALINE AS WELL AS A CONTINUOUS FLOW OF WARM SALINE THAT WAS RUN OVER THE NEEDLE INSERTION SITES. THE TUMOR WAS SUPERFICIAL (APPX 2CM BELOW THE SKIN). 7 ICEROD NEEDLES WERE PLACED AT FAIRLY STEEP ANGLES IN ALTERNATING OPPOSING DIRECTIONS TO ALLOW FOR TUMOR COVERAGE AT A MORE SUPERFICIAL ANGLE. BASED ON THE IMAGING, THE FROST BITE WAS FROM THE SHAFT CONTACTING THE SKIN. IT IS UNKNOWN IF ANY TREATMENT WAS PERFORMED.

  Patient problems: Burn, Thermal

  MAUDE report 8426629 ↗