IceRod® 1.5 CX 90° Cryoablation Needle FPRPR3533Recalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 07290104830587), received between Jun 8, 2017 and Sep 2, 2026 — classified as 29 injuries, 139 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (24 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-0663-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Thermal Decomposition of Device; Noise, Audible

  It was reported that shaft frost occurred.An Icerod CX 90 Degree Needle/VL was selected for use. During the first freeze, the needle frosted up the shaft, and an audible high-pitched noise was noted. The needle was exchanged and the procedure was completed. There were no patient consequences as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569603 ↗
• MalfunctionApr 1, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED A GAS/AIR LEAK OCCURRED ON THE SHAFT OF THE DEVICE. DURING TESTING FOR A RENAL CRYOABLATION PROCEDURE TO TREAT A RENAL CELL CARCINOMA (RCC), AN ICEROD CX 90 DEGREE NEEDLE/VL WAS REPORTED TO HAVE A GAS/AIR LEAK FROM THE SHAFT OF THE DEVICE, BUBBLES WERE PRESENT. ANOTHER DEVICE OF A DIFFERENT MODEL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740639 ↗
• MalfunctionMar 4, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. MULTIPLE NEEDLES WERE SELECTED FOR USE IN THIS RENAL CRYOABLATION PROCEDURE FOR RENAL CELL CARCINOMA. DURING THE PROCEDURE, FROST FORMED ON THE NEEDLE SHAFT OF ONE OF THE ICEROD CX 90 DEGREE NEEDLE/VL. THE STAFF USED PROTECTIVE MEASURES (WARM SALINE) ON THE SKIN WHERE THE FROST ON THE NEEDLE MET THE SKIN; HOWEVER, THE PATIENT STILL EXPERIENCED A SKIN BURN. THE PATIENT WAS BEING MONITORED FOR FROSTBITE, BUT THERE WERE NO OTHER ACTIONS TAKEN AS A RESULT. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21519385 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMORRHAGE, HEMATURIA AND A DROP IN SYSTOLIC BLOOD PRESSURE, REQUIRING ADDITIONAL INTERVENTIONS. AN ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A CRYOABLATION PROCEDURE ON THE KIDNEY. THERE WERE NO DEVICE MALFUNCTIONS; HOWEVER, A HEMORRHAGE DEVELOPED DURING THE PROCEDURE. THE AMOUNT OF HEMORRHAGE IN THE ABDOMEN WAS NOT IMMEDIATELY CONCERNING. AFTER THE PROCEDURE, THERE WAS GROSS HEMATURIA AS WELL AS A TRANSIENT DROP IN SYSTOLIC BLOOD PRESSURE. HEMOGLOBIN WAS MEASURED, AND THERE WAS NO SIGNIFICANT DROP. THE PATIENT WAS BROUGHT TO THE RECOVERY ROOM FOR ATTENTIVE MONITORING WHERE THEY EXPERIENCED ANOTHER SYSTOLIC BLOOD PRESSURE DROP. AN ACTIVE BLEED WAS SUSPECTED SO THE PATIENT WAS BROUGHT TO THE INTERVENTIONAL RADIOLOGY SUITE FOR AN URGENT EMBOLIZATION. ANGIOGRAMS WERE PERFORMED BUT NO OBVIOUS EXTRAVASATION WAS NOTED. THE PROCEDURE WAS CONCLUDED, AND THE PATIENT WAS RETURNED TO THE RECOVERY ROOM. THEIR VITAL SIGNS WERE STABLE FOLLOWING THIS. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED IN THE AFTERNOON TO ASSESS THE HEMORRHAGE. THERE WERE BLOOD CLOTS IN THE BLADDER ON THE CT AND THERE WERE CLOTS IN THE PATIENT'S COLLECTION BAG, S

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 20924505 ↗
• MalfunctionDec 13, 2024Insufficient Cooling; Gas/Air Leak; Insufficient Cooling; Gas/Air Leak

  IT WAS REPORTED THAT AN AIR/GAS LEAK OCCURRED AT THE SHAFT OF THE DEVICE. AN ICEFORCE CX 90 DEGREE NEEDLE WAS SELECTED FOR A DESMOID CRYOABLATION. DURING PREPARATION, BUBBLES WERE NOTED FROM THE SHAFT OF THE DEVICE WHILE INSUFFICIENT ICE OCCURRED. THE NEEDLE WAS FULLY SUBMERGED DURING THE INTEGRITY TESTING. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED WITH A DIFFERENT DEVICE OF THE SAME MODEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922251 ↗
• MalfunctionNov 21, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED A GAS/AIR LEAK OCCURRED ON THE SHAFT OF THE DEVICE. DURING TESTING FOR A CRYOABLATION PROCEDURE TO TREAT A RENAL CELL CARCINOMA, AN ICEROD CX 90 DEGREE NEEDLE WAS REPORTED TO HAVE A GAS/AIR LEAK FROM THE SHAFT OF THE DEVICE. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748866 ↗
• MalfunctionNov 1, 2024Thermal Decomposition of Device; Gas/Air Leak; Thermal Decomposition of Device; Gas/Air Leak

  IT WAS REPORTED FROST WAS PRESENT ON THE SHAFT OF THE DEVICE. DURING THE TEST PERIOD FOR A CRYOABLATION TO TREAT A RENAL TUMOR, AN ICEROD CX 90 DEGREE NEEDLE/VL WAS CHOSEN FOR THE PROCEDURE. FROST APPEARED ON THE ENTIRE SHAFT OF THE DEVICE. A GAS/AIR LEAK WAS OBSERVED FROM THE SHAFT-HANDLE PART OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586657 ↗
• MalfunctionDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15DEC2023. THE ICEROD CX 90 DEGREE NEEDLE WAS RETURNED WITHOUT AN ASSOCIATED COMPLAINT. HOWEVER, DEVICE ANALYSIS REVEALED FROST ON THE NEEDLE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376951 ↗
• InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HEMORRHAGE OCCURRED. AN ICEROD CX 90 DEGREE NEEDLE/VL WAS USED TO TREAT TWO LIVER MASSES. AFTER SUCCESSFUL TREATMENT, AT THE END OF THE FINAL THAW, CAUTERY WAS PERFORMED BY THE NEEDLES. EACH NEEDLE WAS CAUTERIZED FOR 30 SECONDS AND WAS PULLED BACK 29MM, THEN ANOTHER 30 SECONDS CAUTERY, AND SO ON UNTIL THE NEEDLE TRACK WITHIN THE LIVER WAS COMPLETELY CAUTERIZED. NO INITIAL COMPLICATIONS WERE SEEN. THE NEEDLES WERE DISCONNECTED AND DISPOSED OF, AND THE PATIENT WAS BANDAGED. POST-NEEDLE-REMOVAL SCAN WAS SCANNED AND SHOWED THAT WITHIN ONE OF THE NEEDLE TRACK REMNANTS, THERE APPEARED TO BE A SMALL ACTIVE BLEED. IT WAS SCANNED SEVERAL MORE TIMES TO SEE PROGRESSION, AND THE PHYSICIAN DECIDED TO TAKE THE PATIENT TO THE INTERVENTIONAL RADIOLOGIST TO DO AN ANGIOGRAM AND SEE WHAT VESSEL WAS CAUSING THE BLEED. THE BRANCH WAS FOUND AND SUCCESSFULLY EMBOLIZED. THE PATIENT REMAINED AN INPATIENT FOR 3 DAYS BEFORE RECOVERING AND BEING DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18011904 ↗
• MalfunctionSep 15, 2023Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT THERE WAS A GAS LEAK FROM THE NEEDLE SHAFT. A ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT RENAL CELL CARCINOMA. DURING INTEGRITY TESTING FOR PREPARATION, HOWEVER, THE NEEDLE STARTED TO MAKE A HISSING NOISE. ADDITIONALLY, UPON OBSERVATION OF THE NEEDLE IN THE SALINE BATH, TWO AIR BUBBLES WERE SEEN COMING FROM THE NEEDLE SHAFT. NO VISIBLE DAMAGE WAS NOTICED. THE NEEDLE WAS NOT USED AND WAS REPLACED WITH AN ICEPEARL NEEDLE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17755223 ↗
• MalfunctionAug 25, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THERE WAS FROST ON THE NEEDLE SHAFT. AN ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A RIGHT PARAVERTEBRAL MASS CRYOABLATION PROCEDURE TO TREAT A SOFT TISSUE MASS IN THE PROSTATE. DURING THE PROCEDURE, THE NEEDLE STARTED FREEZING WITH THE OTHER NEEDLES USED TOGETHER. HOWEVER, IT WAS OBSERVED THAT THE ICEROD CX 90 DEGREE NEEDLE/VL HAD ICE FORMING ON THE NEEDLE SHAFT. TO PREVENT FROSTBITE, THE NEEDLE WAS EXCHANGED FOR ANOTHER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625623 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THROMBOSIS WAS OBSERVED 5 DAYS AFTER USE OF THE CRYOABLATION DEVICE. ON (B)(6) 2023, PATIENT WENT UNDER A CRYOABLATION PROCEDURE TO TREAT FIBRO-ADIPOSE VASCULAR ANOMALY (FAVA) LOCATED AT HER LEFT CALF. AN ICEROD CX 90 DEGREE NEEDLE / VL WAS USED TO TREAT THE FAVA LESION. THE PROTOCOL USED WAS 10 MIN CRYOABLATION THEN 5 MIN PASSIVE THAW THEN 10 MIN CRYOABLATION AT 70% THEN 2 MINUTES OF ITHAW. THE PATIENT WAS UNDER LIGHT SEDATION, AND THE TREATMENT WENT AS PLANNED. THE SKIN WAS WELL-COLORED AND WARM AT THE END OF CASE. ON MONDAY, (B)(6) 2023, PATIENT DISCUSSED WITH THE SCAN COORDINATOR THAT HER LEFT FOOT WAS RED AND SWOLLEN. SO THE PATIENT WAS PRESCRIBED A DOPPLER THAT WAS PERFORMED AND A LEFT SUPERFICIAL SAPHENE THROMBOSIS WAS DIAGNOSED. ANTICOAGULATION TREATMENT WAS STARTED THE SAME DAY ON (B)(6) 2023. THE PATIENT IS EXPECTED TO FULLY RECOVER FROM THIS CONDITION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17380128 ↗
• MalfunctionMay 24, 2023Insufficient Cooling; Insufficient Heating; Gas/Air Leak; Insufficient Cooling; Insufficient Heating; Gas/Air Leak

  IT WAS REPORTED THAT A NEEDLE SHAFT LEAK OCCURRED. AN ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING PREPARATION, THE NEEDLE WAS BEING TESTED WHEN AN ITHAW MALFUNCTION DISPLAYED. THE TESTING PHASE WAS CONTINUED, BUT THE SAME NEEDLE HAD ABOUT 5 AIR BUBBLES AROUND THE NEEDLE SHAFT AND NO ICE FORMED. THE NEEDLE WAS THEN REMOVED AND REPLACED WITH ANOTHER NEEDLE THAT WORKED AS EXPECTED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991975 ↗
• MalfunctionMay 2, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST FORMED ON THE NEEDLE SHAFT. AN ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A CRYOABLATION PROCEDURE. DURING THE PROCEDURE, HOWEVER, FROST DEVELOPED ON THE NEEDLE SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER PROBE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852474 ↗
• MalfunctionApr 28, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THERE WAS FROST OBSERVED ON THE NEEDLE SHAFT. THIS ICEROD CX 90-DEGREE NEEDLE/VL WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT A TUMOR AND TESTING WAS COMPLETED SUCCESSFULLY. DURING THE PROCEDURE, THIS NEEDLE HAD FROST DEVELOP ALONG THE SHAFT OF THE NEEDLE ALL ALONG THE SKIN UP TO THE HUB. THE NEEDLE WAS EXCHANGED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16838978 ↗
• MalfunctionApr 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AN ICEROD 1.5 CX 90 DEGREE NEEDLE WAS RETURNED TO THE BOSTON SCIENTIFIC COMPLAINT INVESTIGATION SITE WITHOUT AN ASSOCIATED COMPLAINT. HOWEVER, THE DEVICE EVALUATION REVEALED FROST ON THE NEEDLE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828570 ↗
• MalfunctionApr 12, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST OCCURRED ON THE NEEDLE SHAFT. A TISSUE CRYOTHERAPY PROCEDURE WAS PERFORMED USING EIGHT CRYO NEEDLES. ALL THE NEEDLES WERE PLACED IN THE TUMOR. DURING THE FREEZE CYCLE, ONE OF THE EIGHT NEEDLES EXPERIENCED ICE ON THE NEEDLE SHAFT. THE OTHER NEEDLES HAD NO ISSUE. TO PREVENT A PATIENT BURN FROM THE ICE ON THE NEEDLE SHAFT, PROTECTIVE MEASURES WERE PERFORMED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728284 ↗
• MalfunctionMar 17, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A GAS LEAK WAS DETECTED IN THE TIP OF THE NEEDLE. AN ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A CRYOTHERAPY PROCEDURE. WHEN CHECKING THE NEEDLES, HOWEVER, THERE WAS A LEAK DETECTED AT THE TIP OF THE NEEDLE. THE NEEDLE WAS EXCHANGED FOR ANOTHER NEEDLE OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16564814 ↗
• MalfunctionFeb 1, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT FROST WAS OBSERVED ON THE NEEDLE SHAFT. AN ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A CRYOABLATION PROCEDURE TO TREAT CANCER. DURING THE PROCEDURE AT THE 2:00 MINUTE, FROST WAS OBSERVED ALONG THE SHAFT OF THE NEEDLE. THE PROCEDURE WAS STOPPED IMMEDIATELY AT THE 2:20 MINUTE, AND THE FAULTY NEEDLE WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277117 ↗
• MalfunctionJan 20, 2023Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT DURING THE TESTING PHASE, SIX NEEDLES FROM THE SAME LOT HAD A HISSING SOUND. THIS ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLES HISSED LIKE THERE WAS AN AIR LEAK ALONG THE NEEDLE. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218443 ↗
• MalfunctionJan 20, 2023Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT DURING THE TESTING PHASE, SIX NEEDLES FROM THE SAME LOT HAD A HISSING SOUND. THIS ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLES HISSED LIKE THERE WAS AN AIR LEAK ALONG THE NEEDLE. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218442 ↗
• MalfunctionJan 20, 2023Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT DURING THE TESTING PHASE, SIX NEEDLES FROM THE SAME LOT HAD A HISSING SOUND. THIS ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLES HISSED LIKE THERE WAS AN AIR LEAK ALONG THE NEEDLE. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218441 ↗
• MalfunctionJan 20, 2023Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT DURING THE TESTING PHASE, SIX NEEDLES FROM THE SAME LOT HAD A HISSING SOUND. THIS ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLES HISSED LIKE THERE WAS AN AIR LEAK ALONG THE NEEDLE. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218108 ↗
• MalfunctionJan 20, 2023Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT DURING THE TESTING PHASE, SIX NEEDLES FROM THE SAME LOT HAD A HISSING SOUND. THIS ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLES HISSED LIKE THERE WAS AN AIR LEAK ALONG THE NEEDLE. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218098 ↗
• MalfunctionJan 20, 2023Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT DURING THE TESTING PHASE, SIX NEEDLES FROM THE SAME LOT HAD A HISSING SOUND. THIS ICEROD CX 90 DEGREE NEEDLE/VL WAS SELECTED FOR A RENAL CRYOABLATION PROCEDURE. DURING THE TESTING PHASE, WHILE OUTSIDE THE PATIENT, THE NEEDLES HISSED LIKE THERE WAS AN AIR LEAK ALONG THE NEEDLE. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218095 ↗